Fluid control devices and methods of using the same

ABSTRACT

A fluid control device includes an inlet configured to be placed directly or indirectly in fluid communication with a bodily fluid source and an outlet configured to be placed in fluid communication with a fluid collection device. The fluid control device has a first state in which a negative pressure differential produced from an external source such as the fluid collection device is applied to the fluid control device to draw an initial volume of bodily fluid from the bodily fluid source, through the inlet, and into a sequestration portion of the fluid control device. The fluid control device has a second state in which (1) the sequestration portion sequesters the initial volume, and (2) the negative pressure differential draws a subsequent volume of bodily fluid, being substantially free of contaminants, from the bodily fluid source, through the fluid control device, and into the fluid collection device.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. Provisionalpatent application Ser. No. 62/557,530 entitled, “Fluid Control Devicesand Methods of Using the Same,” filed Sep. 12, 2017, the disclosure ofwhich is incorporated herein by reference in its entirety.

This application also claims priority to and the benefit of U.S.Provisional patent application Ser. No. 62/634,569 entitled, “FluidControl Devices and Methods of Using the Same,” filed Feb. 23, 2018, thedisclosure of which is incorporated herein by reference in its entirety.

This application also claims priority to and the benefit of U.S.Provisional patent application Ser. No. 62/678,632 entitled, “FluidControl Devices and Methods of Using the Same,” filed May 31, 2018, thedisclosure of which is incorporated herein by reference in its entirety.

BACKGROUND

The invention relates generally to the parenteral procurement of bodilyfluid samples, and more particularly to fluid diversion, sequestration,and/or isolation devices and methods for procuring bodily fluid sampleswith reduced contaminants such as dermally residing microbes and/orother contaminants exterior to the bodily fluid source.

Health care practitioners routinely perform various types of microbialas well as other broad diagnostic tests on patients using parenterallyobtained bodily fluids. As advanced diagnostic technologies evolve andimprove, the speed, accuracy (both sensitivity and specificity), andvalue of information that can be provided to clinicians continues toimprove. Maintaining the integrity of the bodily fluid sample duringand/or after collection also ensures that analytical diagnostic resultsare representative of the in vivo conditions of a patient. Examples ofdiagnostic technologies that are reliant on high quality,non-contaminated, and/or unadulterated bodily fluid samples include butare not limited to microbial detection, molecular diagnostics, geneticsequencing (e.g., deoxyribonucleic acid (DNA), ribonucleic acid (RNA),next-generation sequencing (NGS), etc.), biomarker identification, andthe like. When biological matter, which can include cells external tothe intended source for sample procurement, and/or other externalcontaminants are inadvertently included in the bodily fluid sample thatis to be analyzed, there is an opportunity for inaccurate test resultsto be derived. In short, when the purity of the sample intended to bederived or collected from a specific bodily fluid source is compromisedduring the specimen procurement process, resultant analytical testresults may be inaccurate, distorted, adulterated, falsely positive,falsely negative, and/or otherwise not representative of the actualcondition of the patient, which in turn, can inform faulty, inaccurate,confused, unsure, low-confidence, and/or otherwise undesired clinicaldecision making.

In some instances, patient samples (e.g., bodily fluids) are tested forthe presence of one or more potentially undesirable microbes, such asbacteria, fungi, or yeast (e.g., Candida). In some instances, microbialtesting may include incubating patient samples in one or more sterileand/or non-sterile vessels that may contain culture media, commonadditives, and/or other types of solutions that are conducive tomicrobial growth. In other instances, the sample in the vessel may beanalyzed directly (i.e., not incubated) and may not contain culturemedia or additives associated with incubating the specimen. In stillother instances, various technologies can be employed to assist in thedetection of the presence of microbes as well as other types ofbiological matter, specific types of cells, biomarkers, proteins,antigens, enzymes, blood components, and/or the like during diagnostictesting. Examples include but are not limited to molecular polymerasechain reaction (PCR), magnetic resonance and other magnetic analyticalplatforms, automated microscopy, spatial clone isolation, flowcytometry, whole blood (“culture free”) specimen analysis (e.g. NGS) andassociated technologies, morphokinetic cellular analysis, and/or othercommon or evolving and advanced technologies utilized in the clinicallaboratory environment to characterize patient specimens and/or todetect, identify, type, categorize, and/or characterize specificorganisms, antibiotic susceptibilities, and/or the like.

In some instances, the detection of the presence of microbes includesallowing the microbes and/or organisms to grow for an amount of time(e.g., a variable amount of time from less than an hour to a few hoursto several days—which can be longer or shorter depending on thediagnostic technology employed). The microbe and/or organism growth canthen be detected by automated, continuous monitoring, and/or othermethods specific to the analytical platform and technology used fordetection, identification, and/or the like.

In culture testing, for example, when microbes are present in thepatient sample, the microbes flourish over time in the culture mediumand, in some instances, automated monitoring technologies can detectcarbon dioxide produced by organism growth. The presence of microbes inthe culture medium (as indicated by observation of carbon dioxide and/orvia other detection methods) suggests the presence of the same microbesin the patient sample which, in turn, suggests the presence of the samemicrobes in the bodily fluid of the patient from whom the sample wasobtained. Accordingly, when microbes are determined to be present in theculture medium (or more generally in the sample used for testing), thepatient may be diagnosed and prescribed one or more antibiotics or othertreatments specifically designed to treat or otherwise remove theundesired microbes from the patient.

Patient samples, however, can become contaminated during procurementand/or otherwise can be susceptible to false positive or false negativeresults. For example, microbes from a bodily surface (e.g., dermallyresiding microbes) that are dislodged during the specimen procurementprocess (which can include needle insertion into a patient, specimenprocurement via a lumen-containing device such as a peripheral IVcatheter (PIV), a central line (PICC) and/or other indwellingcatheter(s), collection with a syringe or any other suitable meansemployed to collect a patient specimen), either directly or indirectlyvia tissue fragments, hair follicles, sweat glands, and other skinadnexal structures, can be subsequently transferred to a culture medium,test vial, or other suitable specimen collection or transfer vessel withthe patient sample and/or included in the specimen that is to beanalyzed for non-culture based testing. Another possible source ofcontamination is from the person drawing the patient sample (e.g., adoctor, phlebotomist, nurse, technician, etc.). Specifically, equipment,supplies, and/or devices used during a patient sample procurementprocess often include multiple fluidic interfaces (by way of example,but not limited to, patient to needle, needle to transfer adapter,transfer adapter to sample vessel, catheter hub to syringe, syringe totransfer adapter, needle/tubing to sample vessels, and/or any otherfluidic interface or any combination thereof) that can each introducepoints of potential contamination. In some instances, such contaminantsmay thrive in a culture medium and/or may be identified by anothernon-culture based diagnostic technology and eventually may yield a falsepositive and/or a false negative microbial test result, which mayinaccurately reflect the presence or lack of such microbes within thepatient (i.e., in vivo).

Such inaccurate results because of contamination and/or other sources ofadulteration that compromise the purity of the sample are a concern whenattempting to diagnose or treat a wide range of suspected illnesses,diseases, infections, patient conditions or other maladies of concern.For example, false negative results from microbial tests may result in amisdiagnosis and/or delayed treatment of a patient illness, which, insome cases, could result in the death of the patient. Conversely, falsepositive results from microbial tests may result in the patient beingunnecessarily subjected to one or more anti-microbial therapies, whichmay cause serious side effects to the patient including, for example,death, as well as produce an unnecessary burden and expense to thehealth care system due to extended length of patient stay and/or othercomplications associated with erroneous treatments. The use ofdiagnostic imaging equipment attributable to these false positiveresults is also a concern from both a cost as well as patient safetyperspective as unnecessary exposure to concentrated radiation associatedwith a variety of imaging procedures (e.g., CT scans) has many knownadverse impacts on long-term patient health.

In some instances, devices and/or systems can be used to reduce thelikelihood of contamination, adulteration, and/or the like of bodilyfluid samples for testing. For example, some known devices can beconfigured to collect, divert, separate, and/or isolate or sequester aninitial volume of bodily fluid that may be more likely to containcontaminants such as dermally residing microbes or the like. Some suchdevices, however, can be cumbersome, non-intuitive, perceived asdifficult to use, inappropriate or unusable as intended for the targetpatient population, etc. In addition, some such devices can requiretraining, user observation, intervention by more than one user, and/orcan otherwise present challenges that can lead to limited efficacy basedon variables including environmental, educational, clinician skill,patient condition, and/or the like. In some instances, such challengescan complicate the collection of consistently high quality samples thatare non-contaminated, sterile, unadulterated, etc., which in turn, canimpact the validity of test result outcomes.

On the other hand, some known passive diversion devices and/or systems(e.g., systems that do not specifically utilize or rely on direct userintervention, interaction, manipulation, and/or the like) may fail toadequately divert, sequester, and/or isolate a clinically desired andefficacious pre-sample volume of bodily fluid due to clinical realitiessuch as, for example, the time required to fill a sequestrationreservoir with a meaningful volume of fluid. In some instances, theoperation of some known passive devices is dependent on a positivepressure applied by a bodily fluid source (e.g., a patient's bloodpressure). The positive pressure applied by the bodily fluid source,however, may be insufficient to result in flow dynamics and/or flowrates that makes use of such devices practical in various clinicalsettings (including emergency rooms and other intensive settings). Forexample, the patient population with symptoms requiring diagnostictesting noted above commonly are in such physical condition thatattaining vascular access and/or collection of bodily fluid samples canbe difficult due to a hypotensive state (i.e., low blood pressure),hypovolemic state (i.e., low blood volume), and/or other physicalchallenges (e.g., severe dehydration, obesity, difficult and/orinaccessible vasculature, etc.). Such states or physical conditions canresult in difficulty in providing sufficient blood flow and/or pressureto achieve passive filling of a sequestration chamber, channel,reservoir, container (or other diversion volume) consistently withsufficient volume to meet clinically validated, evidence-based efficacyand results in diverting, sequestering, and/or isolating contaminantswhich otherwise can lead to distorted, inaccurate, falsely positive,falsely negative, and/or otherwise adulterated diagnostic test results.The challenges associated with this approach (e.g., relying on apositive pressure differential applied by the bodily fluid sourcewithout utilizing a specific external energy source and/or negativepressure to facilitate collection of an appropriate and clinicallyefficacious initial volume of bodily fluid) can render it impractical asfailure rates can be unacceptably high for the fragile patientpopulation from whom these samples are collected.

As such, a need exists for fluid diversion devices and methods forprocuring bodily fluid samples with reduced contaminants such asdermally residing microbes and/or other contaminants exterior to thebodily fluid source that result in consistent bodily fluid collection(e.g., from a general patient population and/or a challenging patientpopulation). Some such devices and methods can include, for example,bodily fluid collection with the assistance of various sources ofexternal energy and/or negative pressure. Furthermore, a need exists forsuch devices that are user-friendly, demonstrate consistent efficacy,and address the challenges associated with collecting samples frompatients with challenging health circumstances and/or physicalcharacteristics that impact the ability to collect bodily fluid samples.

SUMMARY

Devices and methods for procuring bodily fluid samples with reducedcontaminants such as dermally residing microbes and/or othercontaminants exterior to the bodily fluid source are described herein.In some embodiments, a system includes a housing, a flow controller, anda fluid collection device. The housing has an inlet and an outlet, andforms a sequestration portion. The inlet is configured to be placed influid communication with a bodily fluid source. The sequestrationportion is configured to receive an initial volume of bodily fluid fromthe bodily fluid source. The flow controller is at least partiallydisposed in the sequestration portion of the housing and is configuredto transition from a first state to a second state. The fluid collectiondevice is configured to be fluidically coupled to the outlet to producea negative pressure differential within at least a portion of thehousing. The negative pressure differential is operable to draw theinitial volume of bodily fluid into the sequestration portion when theflow controller is in the first state and is operable to draw the samplevolume of bodily fluid through the outlet and into the fluid collectiondevice when the flow controller is in the second state.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of a fluid control device accordingto an embodiment.

FIGS. 2-5 are various views of a fluid control device according to anembodiment.

FIGS. 6-8 are various views of a fluid control device according to anembodiment.

FIGS. 9 and 10 are front view illustrations of a fluid control device ina first operating mode and a second operating mode, respectively,according to an embodiment.

FIGS. 11 and 12 are front view illustrations of a fluid control devicein a first operating mode and a second operating mode, respectively,according to an embodiment.

FIGS. 13-15B are various views of a fluid control device according to anembodiment.

FIGS. 16-18 are various views of a fluid control device according to anembodiment.

FIGS. 19-25 are various views of a fluid control device according to anembodiment.

FIGS. 26-28 are each a perspective view of a fluid control deviceaccording to different embodiments.

FIGS. 29-34 are various views of a fluid control device according to anembodiment.

FIGS. 35-40 are various views of a fluid control device according to anembodiment.

FIGS. 41-44 are various views of a fluid control device according to anembodiment.

FIGS. 45-50 are various views of a fluid control device according to anembodiment.

FIGS. 51 and 52 are cross-sectional views of a fluid control deviceaccording to an embodiment.

FIG. 53 is a flowchart illustrating a method of using a fluid controldevice according to an embodiment.

DETAILED DESCRIPTION

Devices and methods for collecting, diverting, sequestering, isolating,etc. an initial volume of bodily fluid to reduce contamination insubsequently procured bodily fluid samples are described herein. Any ofthe fluid control devices described herein can be configured to receive,procure, and/or transfer a flow, bolus, volume, etc., of bodily fluid. Afirst reservoir, channel, flow path, or portion of the device canreceive an initial amount of the bodily fluid flow, which then can besubstantially or fully sequestered (e.g., contained or retained,circumvented, isolated, segregated, vapor-locked, separated, and/or thelike) in or by the first reservoir or first portion of the device. Insome instances, contaminants such as dermally residing microbes or thelike can be included and/or entrained in the initial amount of thebodily fluid and likewise are sequestered in or by the first reservoiror first portion of the device. Once the initial amount is sequestered,any subsequent amount of the bodily fluid flow can be diverted,channeled, directed, flow controlled (e.g., manually, automatically,and/or semi-automatically) to a second reservoir, second portion of thedevice, and/or any additional flow path(s). Thus, with the initialamount sequestered, any additional and/or subsequent amount(s) of bodilyfluid flow are substantially free from contaminants that may otherwiseproduce inaccurate, distorted, adulterated, falsely positive, falselynegative, etc., results in some diagnostics and/or testing. In someinstances, the initial amount of bodily fluid also can be used, forexample, in other testing such as those less affected by the presence ofcontaminants, can be discarded as a waste volume, can be infused backinto the patient, and/or can be used for any other suitable clinicalapplication.

In some embodiments, a feature of the fluid control devices and/ormethods described herein is the use of an external negative pressuresource (e.g., provided by a fluid collection device or any othersuitable means) to (1) overcome physical patient challenges which canlimit and/or prevent a sufficient pressure differential (e.g., adifferential in blood pressure to ambient air pressure) to fully engagethe sequestration chamber and/or to transition fluid flow to the fluidcollection device; (2) result in proper filling of the sequestrationchamber with a clinically validated and/or desirable volume of bodilyfluid; (3) result in efficient, timely, and/or user-accepted consistencywith bodily fluid collection process; and/or (4) provide a means ofmanipulating and/or automatically transitioning fluid flow (e.g.,movement of physical components of the system or changing, switching,engaging, and/or otherwise employing or achieving desired fluid flowdynamics) to enable sequestration and/or isolation of the initial sampleand collection of a subsequent sample.

In some embodiments, a fluid control device includes an inlet and anoutlet. The inlet is configured to be placed in fluid communication witha bodily fluid source or an intermediary bodily fluid transfer deviceand the outlet is configured to be placed in fluid communication with afluid collection device such as, for example, a sample reservoir, asyringe, a lumen-containing device, and/or any other suitable bodilyfluid collection and/or transfer device. The fluid control device has afirst state in which a negative pressure differential produced from anexternal source (e.g., the fluid collection device such as a samplereservoir, a syringe, a vessel, and/or any suitable intermediary fluidreservoir) is applied to the fluid control device to draw an initialvolume of bodily fluid from the bodily fluid source, through the inlet,and into a sequestration and/or diversion portion of the fluid controldevice (which can be formed by or in the fluid control device or coupledthereto). The fluid control device has a second state in which (1) thesequestration chamber sequesters the initial volume, and (2) thenegative pressure differential draws a subsequent volume of bodilyfluid, being substantially free of contaminants, from the bodily fluidsource, through the fluid control device, and into the fluid collectiondevice.

In some embodiments, a system includes a housing, a flow controller, anda fluid collection device. The housing has an inlet and an outlet, andforms a sequestration portion. The inlet is configured to be placed influid communication with a bodily fluid source. The sequestrationportion is configured to receive an initial volume of bodily fluid fromthe bodily fluid source. The flow controller is at least partiallydisposed in the sequestration portion of the housing and is configuredto transition from a first state to a second state. The fluid collectiondevice is configured to be fluidically coupled to the outlet to producea negative pressure differential within at least a portion of thehousing. The negative pressure differential is operable to draw theinitial volume of bodily fluid into the sequestration portion when theflow controller is in the first state and is operable to draw the samplevolume of bodily fluid through the outlet and into the fluid collectiondevice when the flow controller is in the second state.

In some embodiments, an apparatus includes a housing and an actuatorcoupled to the housing. The housing has an inlet configured to be placedin fluid communication with a bodily fluid source and an outletconfigured be placed in fluid communication with a fluid collectiondevice. The housing forms a sequestration portion that is configured toreceive an initial volume of bodily fluid from the bodily fluid source.The actuator has a first configuration in which a first fluid flow pathplaces the inlet in fluid communication with the sequestration portionand a second configuration in which a second fluid flow path places theinlet in fluid communication with the outlet. The fluid collectiondevice is configured to be placed in fluid communication with the outletto produce a negative pressure differential (1) within the first fluidflow path that is operable to draw the initial volume of bodily fluidinto the sequestration portion when the actuator is in the firstconfiguration, and (2) within the second fluid flow path that isoperable to draw a sample volume of bodily fluid into the fluidcollection device when the actuator is in the second configuration.

In some embodiments, a method of using a fluid control device to obtaina bodily fluid sample with reduced contamination includes establishingfluid communication between a bodily fluid source and an inlet of thefluid control device. A fluid collection device is coupled to an outletof the fluid control device and is configured to produce a negativepressure differential within at least a portion of the fluid controldevice. An initial volume of bodily fluid is received from the inlet andinto a sequestration portion of the fluid control device in response tothe negative pressure differential. In response to contact with aportion of the initial volume of bodily fluid, a flow controllerdisposed in the sequestration portion is transitioned from a first statein which the flow controller allows a flow of a gas through the flowcontroller and prevents a flow of bodily fluid through the flowcontroller, to a second state in which the flow controller prevents aflow of gas and bodily fluid through the flow controller. The initialvolume of bodily fluid is sequestered in the sequestration portion afterthe flow controller is transitioned to the second state and a subsequentvolume of bodily fluid is transferred from the inlet to an outlet influid communication with a fluid collection device.

As used in this specification and the claims, the singular forms “a,”“an” and “the” include plural referents unless the context clearlydictates otherwise. Thus, for example, the term “a member” is intendedto mean a single member or a combination of members, “a material” isintended to mean one or more materials, or a combination thereof.

As used herein, the terms “about,” “approximate,” and/or “substantially”when used in connection with stated value and/or other geometricrelationships is intended to convey that the structure so defined isnominally the value stated and/or the geometric relationship described.In some instances, the terms “about,” “approximately,” and/or“substantially” can generally mean and/or can generally contemplate plusor minus 10% of the value or relationship stated. For example, about0.01 would include 0.009 and 0.011, about 0.5 would include 0.45 and0.55, about 10 would include 9 to 11, and about 1000 would include 900to 1100. While a value stated may be desirable, it should be understoodthat some variance may occur as a result of, for example, manufacturingtolerances or other practical considerations (such as, for example, thepressure or force applied through a portion of a device, conduit, lumen,etc.). Accordingly, the terms “about,” “approximately,” and/or“substantially” can be used herein to account for such tolerances and/orconsiderations.

As used herein, “bodily fluid” can include any fluid obtained directlyor indirectly from a body of a patient. For example, “bodily fluid”includes, but is not limited to, blood, cerebrospinal fluid, urine,bile, lymph, saliva, synovial fluid, serous fluid, pleural fluid,amniotic fluid, mucus, sputum, vitreous, air, and the like, or anycombination thereof.

As used herein, the words “proximal” and “distal” refer to the directioncloser to and away from, respectively, a user who would place the deviceinto contact with a patient. Thus, for example, the end of a devicefirst touching the body of the patient would be the distal end, whilethe opposite end of the device (e.g., the end of the device beingmanipulated by the user) would be the proximal end of the device.

As described in further detail herein, any of the devices and methodscan be used to procure bodily fluid samples with reduced contaminationby, for example, diverting a “pre-sample” volume of bodily fluid priorto collecting a “sample” volume of bodily fluid. Each of the terms“pre-sample,” “first,” and/or “initial,” can be used interchangeably todescribe and/or refer to an amount, portion, or volume of bodily fluidthat is transferred, diverted, and/or sequestered prior to procuring the“sample” volume. In some embodiments, the terms “pre-sample,” “first,”and/or “initial” can refer to a predetermined, defined, desired, orgiven volume, portion, or amount of bodily fluid. For example, in someembodiments, a predetermined and/or desired pre-sample volume of bodilyfluid can be about 0.1 milliliter (mL), about 0.2 mL, about 0.3 mL,about 0.4 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL,about 4.0 mL, about 5.0 mL, about 10.0 mL, about 20 mL, about 50 mL,and/or any volume or fraction of a volume therebetween. In otherembodiments, the pre-sample volume can be greater than 50 mL or lessthan 0.1 mL. In some specific embodiments, a predetermined and/ordesired pre-sample volume can be between about 0.1 mL and about 5.0 mL.In other embodiments, the pre-sample volume can be, for example, a dropof bodily fluid, a few drops of bodily fluid, a combined volume of anynumber of lumen that form, for example, a flow path (or portion thereof)from the bodily fluid source to an initial collection chamber, portion,reservoir, etc. (e.g., a sequestration chamber).

On the other hand, the terms “sample,” “second,” and/or “subsequent”when used in the context of a volume of bodily fluid can refer to avolume, portion, or amount of bodily fluid that is either a randomvolume or a predetermined or desired volume of bodily fluid collectedafter transferring, diverting, sequestering, and/or isolating thepre-sample volume of bodily fluid. For example, in some embodiments, adesired sample volume of bodily fluid can be about 10 mL to about 60 mL.In other embodiments, a desired sample volume of bodily fluid can beless than 10 mL or greater than 60 mL. In some embodiments, for example,a sample volume can be at least partially based on one or more tests,assays, analyses, and/or processes to be performed on the sample volume.

The embodiments described herein can be configured to selectivelytransfer bodily fluid to one or more fluid collection device(s). In someembodiments, a fluid collection device can include, but is not limitedto, any suitable vessel, container, reservoir, bottle, adapter, dish,vial, syringe, device, diagnostic and/or testing machine, and/or thelike. By way of specific example, in some instances, any of theembodiments and/or methods described herein can be used to transfer asample volume into a sample reservoir such as any of those described indetail in U.S. Pat. No. 8,197,420 entitled, “Systems and Methods forParenterally Procuring Bodily-Fluid Samples with Reduced Contamination,”filed Dec. 13, 2007 (“the '420 patent”), the disclosure of which isincorporated herein by reference in its entirety.

In some embodiments, a sample reservoir can be a sample or culturebottle such as, for example, an aerobic culture bottle or an anaerobicculture bottle. In this manner, the culture bottle can receive a bodilyfluid sample, which can then be tested (e.g., via in vitro diagnostic(IVD) tests, and/or any other suitable test) for the presence of, forexample, Gram-Positive bacteria, Gram-Negative bacteria, yeast, fungi,and/or any other organism. In some instances, the culture bottle canreceive a bodily fluid sample and the culture medium (disposed therein)can be tested for the presence of any suitable organism. If such a testof the culture medium yields a positive result, the culture medium canbe subsequently tested using a PCR-based system to identify a specificorganism. Moreover, as described in further detail herein, in someinstances, diverting a pre-sample or initial volume of bodily fluid canreduce and/or substantially eliminate contaminants in the bodily fluidsample that may otherwise lead to inaccurate test results.

Any of the sample containers, reservoirs, bottles, dishes, vials, etc.,described herein can be devoid of contents prior to receiving a samplevolume of bodily fluid or can include, for example, any suitableadditive, culture medium, substances, enzymes, oils, fluids, and/or thelike. For example, in some embodiments, a sample reservoir can includean aerobic or anaerobic culture medium (e.g., a nutrient rich and/orenvironmentally controlled medium to promote growth, and/or othersuitable medium(s)), which occupies at least a portion of the innervolume defined by the sample reservoir. In some embodiments, a samplereservoir can include, for example, any suitable additive or the likesuch as, heparin, citrate, ethylenediaminetetraacetic acid (EDTA),oxalate, SPS, and/or the like, which similarly occupies at least aportion of the inner volume defined by the sample reservoir. In otherembodiments, a sample reservoir can be any suitable container used tocollect a specimen.

While the term “culture medium” can be used to describe a substanceconfigured to react with organisms in a bodily fluid (e.g.,microorganisms such as bacteria) and the term “additive” can be used todescribe a substance configured to react with portions of the bodilyfluid (e.g., constituent cells of blood, serum, synovial fluid, etc.),it should be understood that a sample reservoir can include any suitablesubstance, liquid, solid, powder, lyophilized compound, gas, etc.Moreover, when referring to an “additive” within a sample reservoir, itshould be understood that the additive could be a culture medium, suchas an aerobic culture medium and/or an anaerobic culture mediumcontained in a culture bottle, an additive and/or any other suitablesubstance or combination of substances contained in a culture bottleand/or any other suitable reservoir such as those described above. Thatis to say, the embodiments described herein can be used with anysuitable fluid reservoir or the like containing any suitable substance.Furthermore, any of the embodiments and/or methods described herein canbe used to transfer a volume of bodily fluid to a reservoir (or thelike) that does not contain a culture medium, additive, and/or any othersubstance prior to receiving a flow of bodily fluid.

While some of the embodiments are described herein as being used forprocuring bodily fluid for one or more culture sample testing, it shouldbe understood that the embodiments are not limited to such a use. Any ofthe embodiments and/or methods described herein can be used to transfera flow of bodily fluid to any suitable device that is placed in fluidcommunication therewith. Thus, while specific examples are describedherein, the devices, methods, and/or concepts are not intended to belimited to such specific examples.

The embodiments described herein and/or portions thereof can be formedor constructed of one or more biocompatible materials. In someembodiments, the biocompatible materials can be selected based on one ormore properties of the constituent material such as, for example,stiffness, toughness, durometer, bioreactivity, etc. Examples ofsuitable biocompatible materials include metals, glasses, ceramics, orpolymers. Examples of suitable metals include pharmaceutical gradestainless steel, gold, titanium, nickel, iron, platinum, tin, chromium,copper, and/or alloys thereof. A polymer material may be biodegradableor non-biodegradable. Examples of suitable biodegradable polymersinclude polylactides, polyglycolides, polylactide-co-glycolides (PLGA),polyanhydrides, polyorthoesters, polyetheresters, polycaprolactones,polyesteramides, poly(butyric acid), poly(valeric acid), polyurethanes,and/or blends and copolymers thereof. Examples of non-biodegradablepolymers include nylons, polyesters, polycarbonates, polyacrylates,polymers of ethylene-vinyl acetates and other acyl substituted celluloseacetates, non-degradable polyurethanes, polystyrenes, polyvinylchloride, polyvinyl fluoride, poly(vinyl imidazole), chlorosulphonatepolyolefins, polyethylene oxide, and/or blends and copolymers thereof.

The embodiments described herein and/or portions thereof can includecomponents formed of one or more parts, features, structures, etc. Whenreferring to such components it should be understood that the componentscan be formed by a singular part having any number of sections, regions,portions, and/or characteristics, or can be formed by multiple parts orfeatures. For example, when referring to a structure such as a wall orchamber, the structure can be considered as a single structure withmultiple portions, or multiple, distinct substructures or the likecoupled to form the structure. Thus, a monolithically constructedstructure can include, for example, a set of substructures. Such a setof substructures may include multiple portions that are eithercontinuous or discontinuous from each other. A set of substructures canalso be fabricated from multiple items or components that are producedseparately and are later joined together (e.g., via a weld, an adhesive,or any suitable method).

Referring now to the drawings, FIG. 1 is a schematic illustration of afluid control device 100 according to an embodiment. Generally, thefluid control device 100 (also referred to herein as “control device” or“device”) is configured to withdraw bodily fluid from a patient. A firstportion or amount (e.g., an initial amount) of the withdrawn bodilyfluid is sequestered from a second portion or amount (e.g., a subsequentamount) of the withdrawn bodily fluid which can be subsequently used foradditional testing, discarded, and/or reinfused into the patient. Inthis manner, contaminants or the like can be sequestered within thefirst portion or amount, leaving the second portion or amountsubstantially free of contaminants. The second portion or amount ofbodily fluid can then be used as a biological sample in one or moretests for the purpose of medical diagnosis and/or treatment (e.g., ablood culture test or the like), as described in more detail herein. Thefirst portion or amount of bodily fluid can be discarded as waste or canbe used in any suitable test that is less likely to produce false,inaccurate, distorted, inconsistent, and unreliable results as a resultof potential contaminants contained therein. In other instances, thefirst portion or amount of bodily fluid can be infused back into thepatient.

The control device 100 includes a housing 130 that has and/or forms aninlet 131, at least one outlet 136, and a sequestration chamber 134. Theinlet 131 is configured to fluidically couple to a lumen-containingdevice, which in turn, can place the housing 130 in fluid communicationwith a bodily fluid source. For example, the housing 130 can be coupledto and/or can include a lumen-containing device that is in fluidcommunication with the inlet 131 and that is configured to bepercutaneously disposed in a patient (e.g., a butterfly needle,intravenous (IV) catheter, peripherally inserted central catheter(PICC), syringe, sterile tubing, intermediary lumen-containing device,and/or bodily-fluid transfer device or the like). Thus, bodily fluid canbe transferred from the patient and/or other bodily fluid source to thehousing 130 via the inlet 131, as described in further detail herein.The outlet(s) 136 can be placed in fluid communication with a fluidcollection device 180 (e.g., a fluid or sample reservoir, syringe,evacuated container, etc.). As such, the control device 100 can be usedand/or manipulated to selectively transfer a volume of bodily fluid froma bodily fluid source, through the inlet 131, the housing 130, and theoutlet(s) 136 to the fluid collection device 180, as described infurther detail herein.

The housing 130 defines one or more fluid flow paths 133 between theinlet 131 and the sequestration chamber 134 and/or one or more fluidflow paths 154 between the inlet 131 and the outlet 136. The housing 130of the device 100 can be any suitable shape, size, and/or configuration.For example, in some embodiments, the housing 130 can have a size thatis at least partially based on a volume of bodily fluid at leasttemporarily stored, for example, in the sequestration chamber 134. Asdescribed in further detail herein, the control device 100 and/or thehousing 130 can be configured to transition between operating modes suchthat bodily fluid flows through at least one of the fluid flow paths 133and/or 154. Moreover, the control device 100 and/or the housing 130 canbe configured to transition automatically (e.g., based on pressuredifferential, time, electronically, saturation of a membrane, anabsorbent and/or barrier material, etc.) or via intervention (e.g., userintervention, mechanical intervention, or the like).

The sequestration chamber 134 is at least temporarily placed in fluidcommunication with the inlet 131 via the fluid flow path(s) 133. Asdescribed in further detail herein, the sequestration chamber 134 isconfigured to (1) receive a flow and/or volume of bodily fluid from theinlet 131 and (2) sequester (e.g., separate, segregate, contain, retain,isolate, etc.) the flow and/or volume of bodily fluid therein. Thesequestration chamber 134 can have any suitable arrangement such as, forexample, those described herein with respect to specific embodiments. Itshould be understood, however, that the control device 100 and/or thehousing 130 can have a sequestration chamber 134 in any suitablearrangement and is not intended to be limited to those shown anddescribed herein. For example, in some embodiments, the sequestrationchamber 134 can be at least partially formed by the housing 130. Inother embodiments, the sequestration chamber 134 can be a reservoirplaced and/or disposed within a portion of the housing 130. In otherembodiments, the sequestration chamber 134 can be formed and/or definedby a portion of the fluid flow path 133. That is to say, the housing 130can define one or more lumens and/or can include one or more lumendefining device(s) configured to receive a flow of bodily fluid from theinlet 131, thereby defining the fluid flow path 133. In suchembodiments, at least a portion of the lumen and/or a portion of thelumen defining device(s) can form and/or can define the sequestrationchamber 134.

The sequestration chamber 134 can have any suitable volume and/or fluidcapacity. For example, in some embodiments, the sequestration chamber134 can have a volume and/or fluid capacity between about 0.25 mL andabout 5.0 mL. In some embodiments, the sequestration chamber 134 canhave a volume measured in terms of an amount of bodily fluid (e.g., theinitial or first amount of bodily fluid) configured to be transferred inthe sequestration chamber 134. For example, in some embodiments, thesequestration chamber 134 can have a volume sufficient to receive aninitial volume of bodily fluid as small as a microliter or less ofbodily fluid (e.g., a volume as small as 20 drops of bodily fluid, 10drops of bodily fluid, 5 drops of bodily fluid, a single drop of bodilyfluid, or any suitable volume therebetween). In other embodiments, thesequestration chamber 134 can have a volume sufficient to receive aninitial volume of bodily fluid up to, for example, about 5.0 mL, 10.0mL, 15 mL, 20 mL, 30 mL, 40 mL, 50 mL, or more. In some embodiments, thesequestration chamber 134 can have a volume that is equal to a fractionof and/or a multiple of at least some of the volumes of one or morelumen(s) placing the sequestration chamber 134 in fluid communicationwith the bodily fluid source.

Although not shown in FIG. 1 , in some embodiments, the sequestrationchamber 134 can include any suitable arrangement, configuration, and/orfeature, and/or can be formed of one or more materials configured tointeract with a portion of the bodily fluid transferred into thesequestration chamber 134. For example, in some embodiments, the housing130 can include an absorbent and/or hydrophilic material disposed withinthe sequestration chamber 134. Accordingly, when bodily fluid istransferred into the sequestration chamber 134, the absorbent and/orhydrophilic material can absorb, attract, retain, expand, and/orotherwise interact with at least a portion of the bodily fluid, which inturn, can sequester and/or retain at least an initial portion of thebodily fluid within the sequestration chamber 134, as described infurther detail herein. In other embodiments, the sequestration chamber134 can include and/or can be formed of an expandable or collapsiblematerial configured to transition between a first state (e.g., while aninitial portion of the bodily fluid is being transferred into thesequestration chamber 134) to a second state (e.g., after the initialportion of the bodily fluid is transferred into the sequestrationchamber 134). In some embodiments, a force associated with and/orresulting from such a material expanding or collapsing can be operableto transition the housing 130 and/or the device 100 from a first state,position, configuration, etc. to a second state, position,configuration, etc. In some embodiments, the sequestration chamber 134and/or any other suitable portion of the housing 130 can include one ormore chemicals, compounds, and/or the like configured to chemicallyinteract with bodily fluid transferred through a portion of the housing130, which can be operable to transition the control device 100 and/orthe housing 130 between the first state and the second state (e.g., viaa force or any other suitable means).

In some embodiments, the control device 100 and/or the housing 130 caninclude and/or define a flow controller 120 configured to selectivelycontrol a flow of fluids (e.g., gas or liquids) through a portion of thecontrol device 100. For example, in some embodiments, the flowcontroller 120 can control a flow of bodily fluid through the controldevice 100 (or housing 130) and/or otherwise selectively control a flowof bodily fluid through at least one of the fluid flow paths 133 and/or154. The flow controller 120 can be, for example, a valve, a membrane, adiaphragm, a restrictor, a vent, a selectively permeable member (e.g., afluid impermeable barrier or seal that at least selectively allows thepassage of air or gas therethrough), a port, a junction, an actuator,and/or the like, or any suitable combination thereof. In someembodiments, the flow controller 120 can be configured to selectivelycontrol (at least in part) a flow of fluids into and/or out of thesequestration chamber 134 and/or any other suitable portion of thehousing 130. In this context, the flow of fluids, for example, can be aliquid such as water, oil, dampening fluid, bodily fluid, and/or anyother suitable liquid, and/or can be a gas such as air, oxygen, carbondioxide, helium, nitrogen, ethylene oxide, and/or any other suitablegas. For example, in some embodiments, a wall or structure of thehousing 130 can define an opening, aperture, port, orifice, and/or thelike that is in fluid communication with the sequestration chamber 134.In such embodiments, the flow controller 120 can be, for example, asemi-permeable member or membrane disposed in or about the opening toselectively allow a flow of air or gas through the opening whilelimiting or substantially preventing a flow of fluid (e.g., bodily fluidsuch as blood) through the opening.

In some embodiments, one or more flow controllers 120 or the like can beconfigured to facilitate air (or other fluid) displacement through oneor more portions of the control device 100, which in some instances, canresult in a pressure differential across one or more portions of thecontrol device 100 or can result in and/or allow for a pressureequalization across one or more portions of the housing 130. In someembodiments, the control device 100 can be configured to selectivelytransfer a volume of bodily fluid to the sequestration chamber 134 or tothe outlet 136 based at least in part on a pressure differential betweentwo or more portions of the control device 100. In some embodiments, thepressure differential can result from fluidically coupling the outlet136 to the fluid collection device 180, which can define and/or can beconfigured to produce a negative pressure (e.g., an evacuated reservoir,a syringe, a pressure charged canister, and/or other source or potentialenergy to create a vacuum or pressure differential). In otherembodiments, the pressure differential can result from a change involume and/or temperature. In still other embodiments, the pressuredifferential can result from at least a portion of the control device100, the housing 130, and/or other portions of the flow path beingevacuated and/or charged (e.g., the sequestration chamber 134 and/or anyother suitable portion). In some embodiments, the pressure differentialcan be established automatically or via direct or indirect intervention(e.g., by the user).

Moreover, a flow of a fluid (e.g., gas and/or liquid) resulting from apressure differential can be selectively controlled via one or more flowcontrollers 120 that can, for example, transition between one or moreoperating conditions to control the fluid flow. In some embodiments, forexample, the flow controller 120 can be an actuator or the likeconfigured to transition between one or more operating conditions orstates to establish fluid communication between one or more portions ofthe control device 100 and/or configured to sequester one or moreportions of the control device 100 (e.g., the sequestration chamber134). In some embodiments, the flow controller 120 can be member ordevice formed of an absorbent material configured to selectively allowfluid flow therethrough. For example, such an absorbent material can betransitioned from a first state in which the material allows a flow ofgas (e.g., air) therethrough but prevents a flow of liquid (e.g., bodilyfluid) therethrough, to a second state in which the materialsubstantially prevents a flow of gas and liquid therethrough. In otherembodiments, the flow controller 120 can include one or more valves,membranes, diaphragms, and/or the like. In some embodiments, the flowcontroller 120 can include any suitable combination of devices, members,and/or features. It should be understood that the flow controllersincluded in the embodiments described herein are presented by way ofexample and not limitation. Thus, while specific flow controllers aredescribed herein, it should be understood that fluid flow can becontrolled through the control device 100 by any suitable means.

The outlet(s) 136 is/are in fluid communication with and/or is/areconfigured to be placed in fluid communication with the fluid flow paths133 and/or 154. As shown in FIG. 1 , the outlet 136 can be any suitableoutlet, opening, port, stopcock, lock, seal, coupler, valve (e.g.one-way, check valve, duckbill valve, umbrella valve, and/or the like),etc. and is configured to be fluidically coupled to the fluid collectiondevice 180 (e.g., a fluid reservoir, culture sample bottle, syringe,container, vial, dish, receptacle, pump, adapter, and/or any othersuitable collection or transfer device). In some embodiments, the outlet136 can be monolithically formed with the fluid collection device 180.In other embodiments, the outlet 136 can be at least temporarily coupledto the fluid collection device 180 via an adhesive, a resistance fit, amechanical fastener, a threaded coupling, a piercing or puncturingarrangement, any number of mating recesses, and/or any other suitablecoupling or combination thereof. Similarly stated, the outlet 136 can bephysically (e.g., mechanically) and/or fluidically coupled to the fluidcollection device 180 such that an interior volume defined by the fluidcollection device 180 is in fluid communication with the outlet 136. Instill other embodiments, the outlet 136 can be operably coupled to thefluid collection device 180 via an intervening structure (not shown inFIG. 1 ), such as a flexible sterile tubing. In some embodiments, thearrangement of the outlet 136 can be such that the outlet 136 isphysically and/or fluidically sealed prior to coupling to the fluidcollection device 180. In some embodiments, the outlet 136 can betransitioned from a sealed configuration to an unsealed configuration inresponse to being coupled to the fluid collection device 180 and/or inresponse to a negative pressure differential between an environmentwithin the outlet 136 and/or housing 130 and an environment within thefluid collection device 180.

The fluid collection device 180 can be any suitable device for at leasttemporarily containing a bodily fluid, such as, for example, any ofthose described in detail above. For example, in some embodiments, thefluid collection device 180 can be a single-use disposable collectiontube(s), a syringe, a vacuum-based collection tube(s), an intermediarybodily-fluid transfer device, and/or the like. In some embodiments, thefluid collection device 180 can be substantially similar to or the sameas known sample containers such as, for example, a Vacutainer®(manufactured by BD), a BacT/ALERT® SN or BacT/ALERT® FA (manufacturedby Biomerieux, Inc.), and/or any suitable reservoir, vial, microvial,microliter vial, nanoliter vial, container, microcontainer,nanocontainer, and/or the like. In some embodiments, the fluidcollection device 180 can be a sample reservoir that includes a vacuumseal that maintains negative pressure conditions (vacuum conditions)inside the sample reservoir, which in turn, can facilitate withdrawal ofbodily fluid from the patient, through the control device 100, and intothe sample reservoir, via a vacuum or suction force, as described infurther detail herein. In embodiments in which the fluid collectiondevice 180 is an evacuated container or the like, the user can couplethe fluid collection device 180 to the outlet 136 to initiate a flow ofbodily fluid from the patient such that a first or initial portion ofthe bodily fluid is transferred into and sequestered by thesequestration chamber 134 and such that any subsequent portion or volumeof bodily fluid bypasses and/or is otherwise diverted away from thesequestration chamber 134 and flows into the fluid collection device180, as described in further detail herein.

Although the outlet 136 of the control device 100 and/or the housing 130is described above as being fluidically coupled to and/or otherwiseplaced in fluid communication with the fluid collection device 180, inother embodiments, the control device 100 can be used in conjunctionwith any suitable bodily fluid collection device and/or system. Forexample, in some embodiments, the control device 100 described hereincan be used in any suitable fluid transfer device such as thosedescribed in U.S. Patent Publication No. 2015/0342510 entitled, “SterileBodily-Fluid Collection Device and Methods,” filed Jun. 2, 2015(referred to herein as the “'510 publication”), the disclosure of whichis incorporated herein by reference in its entirety. More particularly,the control device 100 can be used in an “all-in-one” or pre-assembleddevice (e.g., such as those described in the '510 publication) toreceive and sequester an initial volume of bodily fluid such thatcontaminants in subsequent volumes of bodily fluid are reduced and/oreliminated.

As described above, the device 100 can be used to procure a bodily fluidsample having reduced contamination from microbes such as, for example,dermally residing microbes, and/or the like. For example, in someinstances, a user such as a doctor, physician, nurse, phlebotomist,technician, etc. can manipulate the device 100 to establish fluidcommunication between the inlet 131 and the bodily fluid source (e.g., avein of a patient, cerebral spinal fluid (CSF) from the spinal cavity,urine collection, and/or the like). As a specific example, in someinstances, the inlet 131 can be coupled to and/or can include a needleor the like that can be manipulated to puncture the skin of the patientand to insert at least a portion of the needle in the vein of thepatient, thereby placing the inlet 131 in fluid communication with thebodily fluid source (e.g., the vein, an IV catheter, a PICC, etc.).

In some embodiments, once the inlet 131 is placed in fluid communicationwith the bodily fluid source (e.g., the portion of the patient), theoutlet 136 can be fluidically coupled to the fluid collection device180. As described above, in some embodiments, the fluid collectiondevice 180 can be any suitable reservoir, container, and/or deviceconfigured to receive a volume of bodily fluid. For example, the fluidcollection device 180 can be an evacuated reservoir or container thatdefines a negative pressure and/or can be a syringe that can bemanipulated to produce a negative pressure. In some instances, couplingthe outlet 136 to the fluid collection device 180 selectively exposes atleast a portion of the fluid flow paths 133 and/or 154 to the negativepressure, thereby resulting in a negative pressure differential operablein drawing bodily fluid from the bodily fluid source (e.g., thepatient), through the inlet 131, and into the housing 130.

In some embodiments, the arrangement of the housing 130 is such thatwhen a volume of bodily fluid is transferred to and/or through the inlet131, an initial portion of the volume of bodily fluid (also referred toherein as an “initial volume” or a “first volume”) flows from the inlet131, through at least a portion of the fluid flow path 133, and into thesequestration chamber 134. That is to say, in some embodiments, thecontrol device 100 and/or the housing 130 can be in first or initialstate in which the initial portion or volume of bodily fluid can flow inor through at least a portion the fluid flow path 133 and into thesequestration chamber 134. For example, in some embodiments, the initialstate of the control device 100 and/or the housing 130 can be one inwhich one or more flow controllers 120 (e.g., valves, membranes,diaphragms, restrictors, vents, air permeable and fluid impermeablebarriers, ports, actuators, and/or the like, or a combination thereof)are in a first state in which the fluid flow path 133 is exposed to thenegative pressure differential via the sequestration chamber 134. Inother words, the negative pressure within or created by the fluidcollection device 180 can result in a negative pressure (or negativepressure differential) within at least a portion of the sequestrationchamber 134 that is operable in drawing an initial flow of bodily fluidinto the sequestration chamber 134 when one or more flow controllers 120is/are in a first or initial state.

For example, in some embodiments, the flow controller 120 can be anactuator or the like that includes a valve (e.g. one-way valve, checkvalve, duckbill valve, umbrella valve, and/or the like), a selectivelypermeable member (e.g., a fluid impermeable barrier or seal that allowsat least selective passage of gas or air), a selectively permeablemembrane, a diaphragm, and/or the like that is at least temporarilyfluidically coupled to a flow path between the fluid collection device180 and the sequestration chamber 134 (e.g., at least a portion of thefluid flow path 154). While in some embodiments the flow controller 120examples noted above can be, for example, known off-the-shelf componentsthat are used in medical devices to control the flow of fluids and air,in other embodiments, the flow controller 120 can be a custom,proprietary, and/or specifically tailored component integrated into thedevice 100. When the flow controller 120 is in the first or initialstate, the flow controller 120 can allow a flow of fluid therethrough inresponse to the negative pressure of the fluid collection device 180. Insome embodiments, the flow controller 120 or a portion or componentthereof is configured to allow only a flow of air or gas through theflow controller 120 and is configured to limit and/or substantiallyprevent a flow of liquid (e.g., bodily fluid) through the flowcontroller 120. As such, the fluid collection device 180 can produce anegative pressure differential within the sequestration chamber 134 thatis operable to draw an initial portion and/or amount of bodily fluidinto the sequestration chamber 134 when the flow controller 120 is in afirst or initial state without allowing the initial portion of bodilyfluid to flow into the fluid flow path 154 and/or otherwise out of thesequestration chamber 134.

Although not shown in FIG. 1 , in some embodiments, the control device100 and/or the housing 130 can include a member, device, mechanism,feature, etc. configured to modulate a magnitude of the negativepressure to which the sequestration chamber 134 is exposed. For example,in some embodiments, a housing can include a valve, a membrane, a porousmaterial, a restrictor, an orifice, and/or any other suitable member,device, and/or feature configured to modulate pressure. In someembodiments, modulating and/or controlling a magnitude of the pressureto which the sequestration chamber 134 is exposed can, in turn, modulatea magnitude of pressure exerted on the bodily fluid and/or within a veinof a patient. In some instances, such pressure modulation can reduce,for example, hemolysis of a blood sample and/or a likelihood ofcollapsing a vein (e.g., which is particularly important in fragilepatients needing microbial and/or other diagnostic testing associatedwith use of the control device 100). In addition, the modulation of thenegative pressure can, for example, at least partially control a rate atwhich the control device 100 transitions between a first configurationor state and a second configuration or state. In some embodiments,modulating the negative pressure can act like a timer. For example, atime between the introduction of the negative pressure differential andthe transitioning of the control device 100 from the first state to thesecond state can be known, predetermined, calculated, and/or controlled.As such, in some instances, modulating the negative pressure can atleast partially control an amount or volume of bodily fluid transferredinto the sequestration chamber 134 (i.e., can control a volume of theinitial amount of bodily fluid).

The initial portion and/or amount of bodily fluid can be any suitablevolume of bodily fluid, as described above. For example, in someinstances, the control device 100 and/or the housing 130 can remain inthe first state until a predetermined and/or desired volume (e.g., theinitial volume) of bodily fluid is transferred to the sequestrationchamber 134. In some embodiments, the initial volume can be associatedwith and/or at least partially based on a volume of the sequestrationchamber 134. In other embodiments, the initial volume can be associatedwith and/or at least partially based on an amount or volume of bodilyfluid that can be absorbed by an absorbent material, an expandablematerial, a hydrophilic material, a wicking material, and/or othersuitable material disposed in the sequestration chamber 134. In otherembodiments, the initial volume of bodily fluid can be associated withand/or at least partially based on an amount or volume of bodily fluidthat can be transferred into the sequestration chamber 134 in apredetermined time. In still other embodiments, the initial volume canbe associated with and/or at least partially based on an amount orvolume of bodily fluid that is sufficient to fully wet or saturate asemi-permeable member or membrane otherwise configured to selectivelyexpose the sequestration chamber 134 to the negative pressure of thefluid collection device 180 (i.e., the flow controller 120 such as anair permeable and liquid impermeable member or membrane). In otherwords, in some embodiments, the initial volume of bodily fluid can be avolume sufficient to transition one or more flow controllers 120 to asecond state (e.g., a saturated or fully wetted state). In still otherembodiments, the control device 100 and/or the housing 130 can beconfigured to transfer a volume of bodily fluid (e.g., the initialvolume) into the sequestration chamber 134 until a pressure differentialbetween the sequestration chamber 134 and the fluid flow path 133 and/orthe bodily fluid source is brought into substantial equilibrium and/oris otherwise reduced below a desired threshold.

After the initial volume of bodily fluid is transferred and/or divertedinto the sequestration chamber 134, the initial volume is sequestered,segregated, retained, contained, isolated, etc. in the sequestrationchamber 134. For example, in some embodiments, the transitioning of theone or more flow controllers 120 from a first state to a second statecan be operable to sequester and/or retain the initial portion of thebodily fluid in the sequestration chamber 134. As described in furtherdetail herein, in some instances, contaminants such as, for example,dermally residing microbes or the like dislodged during the venipunctureevent, other external sources of contamination, colonization ofcatheters and PICC lines that are used to collect samples, and/or thelike can be entrained and/or included in the initial volume of thebodily fluid and thus, are sequestered in the sequestration chamber 134when the initial volume is sequestered therein.

With the initial volume transferred and/or diverted into thesequestration chamber 134, the device 100 can transition to the secondstate in which a subsequent volume(s) of bodily fluid can flow throughat least a portion the fluid flow paths 133 and/or 154 from the inlet131 to the outlet 136. In some embodiments, the control device 100and/or the housing 130 can passively and/or automatically transition(e.g., without user intervention) from the first state to the secondstate once the initial volume of bodily fluid is sequestered in thesequestration chamber 134. For example, in some embodiments, filling thesequestration chamber 134 to capacity and/or fully saturating, wetting,and/or impregnating an absorbent or similar material disposed betweenthe sequestration chamber 134 and the fluid collection device 180 can besuch that further transfer of bodily fluid into the sequestrationchamber 134 is limited and/or substantially prevented due to a removalor diversion of the negative pressure. In other embodiments, the controldevice 100 and/or the housing 130 can be manually transitioned ortransitioned in response to at least an indirect interaction by a user.For example, in some embodiments, a user can transition the controldevice 100 and/or the housing 130 from the first state to the secondstate by actuating an actuator or the like (e.g., actuating the flowcontroller 120 or a portion thereof). In still other embodiments, atleast a portion of the initial volume of bodily fluid can transition thecontrol device 100 and/or the housing 130 from the first state to thesecond state. For example, the control device 100 can include a flowcontroller 120 that is and/or that includes a bodily fluid activatedswitch, valve, port, and/or the like. In other embodiments, a volume ofbodily fluid can move and/or displace one or more flow controller 120(e.g., actuators or the like) that can, for example, open a port, flowpath, and/or outlet. In still other embodiments, a user can manipulatesuch a flow controller 120 (e.g., switch, valve, port, actuator, etc.)to transition the control device 100 and/or the housing 130 from thefirst state to the second state.

With the fluid collection device 180 fluidically coupled to the outlet136 and with the control device 100 and/or the housing 130 being in thesecond state (e.g., the initial volume of bodily fluid is sequestered inor by the sequestration chamber 134), any subsequent volume(s) of thebodily fluid can flow from the inlet 131, through at least one of thefluid flow paths 133 and/or 154, through the outlet 136, and into thefluid collection device 180. Thus, as described above, sequestering theinitial volume of bodily fluid in the sequestration chamber 134 prior tocollecting or procuring one or more sample volumes of bodily fluidreduces and/or substantially eliminates an amount of contaminants in theone or more sample volumes. Moreover, in some embodiments, thearrangement of the control device 100 and/or the housing 130 can be suchthat the control device 100 and/or the housing 130 cannot transition tothe second state prior to collecting and sequestering the initial volumein the sequestration chamber 134.

FIGS. 2-5 illustrate a fluid control device 200 according to anembodiment. The fluid control device 200 can be similar in at least formand/or function to the fluid control device 100 described above withreference to FIG. 1 . Accordingly, portions of the fluid control device200 that can be similar to portions of the fluid control device 100 arenot described in further detail herein.

As shown in FIGS. 2-5 , the fluid control device 200 (also referred toherein as “control device” or “device”) includes a housing 230 having aninlet 231, an outlet 236, and an actuator 250. As described above withreference to the control device 100, the inlet 231 is configured to beplaced in fluid communication with a bodily fluid source to receive aflow of bodily fluid therefrom (e.g., via a lumen-containing device suchas a needle, IV catheter, PICC line, or the like). The outlet 236 isconfigured to be fluidically coupled to a fluid collection device suchas, for example, a sample reservoir, a syringe, and/or otherintermediary bodily fluid transfer device or vessel (e.g., a transferdevice similar to those described in the '510 publication), and/or thelike.

As described above with reference to the housing 130, the housing 230defines one or more fluid flow paths 233 between the inlet 231 and asequestration chamber 234 and/or one or more fluid flow paths 254between the inlet 231 and the outlet 236. The housing 230 of the device200 can be any suitable shape, size, and/or configuration. For example,in some embodiments, the housing 230 can be substantially similar in atleast form and/or function to the housing 130 described above withreference to FIG. 1 . The sequestration chamber 234 of the housing 230is at least temporarily placed in fluid communication with the inlet 231via the fluid flow path(s) 233. Moreover, the sequestration chamber 234can be selectively placed in fluid communication with the fluid flowpath 254 such that at least air or gas can be transferred therebetween,as described in further detail herein.

As described in further detail herein, the sequestration chamber 234 isconfigured to (1) receive a flow and/or volume of bodily fluid from theinlet 231 and (2) sequester (e.g., separate, segregate, contain, retain,isolate, etc.) the flow and/or volume of bodily fluid therein. Thesequestration chamber 234 can have any suitable shape, size, and/orconfiguration. For example, in some embodiments, the sequestrationchamber 234 can have any suitable size, volume, and/or fluid capacitysuch as, for example, those described above with reference to thesequestration chamber 134. In the embodiment shown in FIGS. 2-5 , thesequestration chamber 234 can be at least partially formed by thehousing 230 that defines a lumen or flow path. In some embodiments, atleast a portion of the fluid flow path 233 can extend through a portionof the housing 230 to form and/or define at least a portion of thesequestration chamber 234. As shown in FIGS. 2-5 , the sequestrationchamber 234 and/or a portion of the fluid flow path 233 forming thesequestration chamber 234 can have a serpentine configuration or thelike. In other embodiments, the sequestration chamber 234 can have anysuitable arrangement. For example, in some embodiments, a housing caninclude a sequestration chamber that is formed by a flexible tubing orthe like that can be arranged in any suitable shape and/orconfiguration.

In some embodiments, the housing 230 and/or the sequestration chamber234 can include, form, and/or define a flow controller 242. The flowcontroller 242 can be, for example, a valve, membrane, diaphragm,restrictor, vent, a selectively permeable member (e.g., a fluidimpermeable barrier or seal that allows at least selective passage ofgas or air such as, for example, a blood barrier and/or the like), port,etc. (collectively referred to herein as a “flow controller”) configuredto selectively control (at least in part) a flow of fluids into and/orout of the sequestration chamber 234 and/or any other suitable portionof the housing 230. More particularly, in the embodiment shown in FIGS.2-5 , the flow controller 242 is a selectively permeable fluid barrier(e.g., a blood barrier) that includes and/or is formed of a porousmaterial configured to selectively allow a flow of gas therethrough butto prevent a flow of a liquid therethrough.

As shown, the flow controller 242 is positioned within the housing 230to selectively establish fluid communication between the sequestrationchamber 234 and the fluid flow path 254. Thus, with the flow controller242 being configured as a semi-permeable member, the flow controller 242can be configured to at least temporarily allow a gas or air to transferbetween the fluid flow path 254 and the sequestration chamber 234 andcan be configured to substantially prevent a flow of liquid between thefluid flow path 254 and the sequestration chamber 234, as described infurther detail herein.

The outlet 236 of the housing 230 is in fluid communication with and/oris configured to be placed in fluid communication with the fluid flowpaths 233 and/or 254. As shown in FIGS. 2-5 , the outlet 236 can be anysuitable outlet, opening, port, lock, seal, coupler, etc. and isconfigured to be fluidically coupled to a fluid collection device suchas a sample reservoir, a syringe, container, and/or other sample vessel.In some embodiments, the outlet 236 can be monolithically formed withthe fluid collection device or can be at least temporarily coupled tothe fluid collection device, as described above with reference to theoutlet 136 of the housing 130. The fluid collection device can be anysuitable reservoir, container, and/or device for containing a bodilyfluid, such as, for example, any of those described in detail above withreference to the fluid collection device 180. More particularly, in someembodiments, the outlet 236 can be configured to couple to an evacuatedsample reservoir. As such, the user can couple the sample reservoir tothe outlet 236 to initiate a flow of bodily fluid from the patient suchthat a first or initial portion of the bodily fluid is transferred intoand sequestered by the sequestration chamber 234 and such that anysubsequent portion or volume of bodily fluid bypasses and/or isotherwise diverted away from the sequestration chamber 234 and flowsinto the sample reservoir.

As shown in FIGS. 3-5 , the housing 230 includes and/or is coupled tothe actuator 250 configured to selectively control a flow of bodilyfluid through the housing 230. More particularly, the actuator 250 isdisposed, for example, between a portion of the fluid flow path 233 anda portion of the fluid flow path 254. While the actuator 250 is shown inFIGS. 3-5 as being positioned apart from, away from, and/or downstreamof a junction between the fluid flow path 233 and the sequestrationchamber 234, in other embodiments, the actuator 250 can be disposed atany suitable position within the housing 230. For example, in someembodiments, the actuator 250 can be positioned at and/or can form atleast a portion of a junction between the fluid flow path 233, thesequestration chamber 234, and the fluid flow path 254.

The actuator 250 can be any suitable shape, size, and/or configuration.For example, in some embodiments, the actuator 250 can be any suitablemember or device configured to transition between a first state and asecond state. In the embodiment shown in FIGS. 2-5 , the actuator 250 isconfigured to isolate, sequester, separate, and/or otherwise preventfluid communication between the fluid flow path 233 and the fluid flowpath 254 when in the first state and is configured to place the fluidflow path 233 in fluid communication with the fluid flow path 254 whenin the second state. In some embodiments, for example, the actuator 250can be a valve, plunger, seal, membrane, flap, plate, and/or the like.As shown, for example, in FIG. 5 , the actuator 250 can include one ormore seals 265 configured to selectively establish fluid communicationbetween the fluid flow channels 233 and 254 when the actuator 250 istransitioned from a first state to a second state (e.g., pressed,rotated, moved, activated, switched, slid, etc.).

Although the actuator 250 is particularly shown in FIGS. 2-5 anddescribed above, in other embodiments, the control device 200 caninclude any suitable actuator or device configured to selectivelyestablish fluid communication between the fluid flow path 233 and 254.Thus, while particularly shown in FIGS. 2-5 , it should be understoodthat the control device 200 is presented by way of example only and notlimitation. For example, while the actuator 250 is shown in FIGS. 2-5 asbeing disposed in a given position, in other embodiments, the actuator250 can be placed at any suitable position along the housing 230. By wayof example, in some embodiments, the actuator 250 can be disposed at thejunction between the fluid flow path 233, the sequestration chamber 234,and the inlet 231. In such embodiments, a flow of bodily fluid can flowdirectly from the inlet 231 and into the sequestration chamber 234 whenthe actuator 250 is in the first state and can flow directly from theinlet 231 to the fluid flow path 254 when the actuator 250 is in thesecond state. In other words, the actuator 250 can form a portion of thesequestration chamber 234 such that when the actuator 250 is in thefirst state, bodily fluid flows from the inlet directly into thesequestration chamber 234. When the actuator 250 is actuated, placed,and/or transitioned to the second state, the actuator 250 can, forexample, allow bodily fluid to flow directly from the inlet 231 to thefluid flow path 233. In such embodiments, the actuator 250 can preventthe formation of a junction between the inlet 231, the sequestrationchamber 234, and the fluid flow path 233. Moreover, when in the secondstate, the actuator 250 can be operable in at least partiallysequestering the sequestration chamber 234 from the inlet 231 and/or thefluid flow path 233.

In addition, the actuator 250 can be actuated and/or transitioned in anysuitable manner. For example, in some embodiments, the actuator 250 cantransition between the first and the second state in response to amanual actuation by the user (e.g., exerting a manual force on a button,slider, switch, rotational member, etc.). In other embodiments, theactuator 250 can be configured to automatically transition between thefirst state and the second state in response to a pressure differential(or lack thereof), a change in potential or kinetic energy, a change incomposition or configuration (e.g., a portion of the actuator could atleast partially dissolve or transform), and/or the like. In still otherembodiments, the actuator 250 can be mechanically and/or electricallyactuated or transitioned based on a predetermined time, volumetric flowrate, flow velocity, etc. While examples of actuators and/or ways inwhich an actuator can transition are provided herein, it should beunderstood that they have been presented by way of example only and notlimitation. Thus, a control device 200 can include any suitable actuatorconfigured to transition in any suitable manner.

As described above, the device 200 can be used to procure a bodily fluidsample having reduced contamination from microbes such as, for example,dermally residing microbes, and/or the like. For example, in someinstances, a user such as a doctor, physician, nurse, phlebotomist,technician, etc. can manipulate the device 200 to establish fluidcommunication between the inlet 231 and the bodily fluid source (e.g., avein of a patient). Once the inlet 231 is placed in fluid communicationwith the bodily fluid source (e.g., the portion of the patient), theoutlet 236 can be fluidically coupled to the fluid collection device. Asdescribed above, in the embodiment shown in FIGS. 2-5 , the fluidcollection device can be, for example, an evacuated reservoir orcontainer that defines a negative pressure and/or can be any othersuitable negative pressure source.

Coupling the outlet 236 to the fluid collection device selectivelyexposes at least a portion of the fluid flow path 254 to the negativepressure within the fluid collection device. As described above, theflow controller 242 is in fluid communication with the fluid flow path254 and the sequestration chamber 234. Thus, coupling the outlet 236 tothe fluid collection device exposes the sequestration chamber to thenegative pressure of the fluid collection device, thereby resulting in anegative pressure differential operable in drawing bodily fluid from thebodily fluid source (e.g., the patient), through the inlet 231, and intothe housing 230. As described above with reference to the control device100, the arrangement of the housing 230 is such that when a volume ofbodily fluid is transferred to and/or through the inlet 231, an initialportion of the volume of bodily fluid (also referred to herein as an“initial volume” or a “first volume”) flows from the inlet 231, throughat least a portion of the fluid flow path 233, and into thesequestration chamber 234. That is to say, in some embodiments, thecontrol device 200 and/or the housing 230 can be in first or initialstate in which the initial portion or volume of bodily fluid can flow inor through at least a portion the fluid flow path 233 and into thesequestration chamber 234.

As described above, the housing 230 and/or the control device 200 can bein the initial state when the flow controller 242 and the actuator 250are in a first state, position, configuration, etc. As such, theactuator 250 isolates, separates, segregates, sequesters and/orotherwise prevents direct fluid communication between the fluid flowpaths 233 and 254. In addition, the inlet 231 is exposed to the negativepressure differential via the sequestration chamber 234. In other words,the negative pressure within the fluid collection device can result in anegative pressure (or negative pressure differential) within at least aportion of the sequestration chamber 234 that is operable in drawing aninitial flow of bodily fluid from the inlet 233 into the sequestrationchamber 234 when the housing 230 and/or control device 200 is in thefirst or initial state.

When the flow controller 242 is in the first or initial state, the flowcontroller 242 can allow a flow of fluid (e.g., a gas or air)therethrough in response to the negative pressure of the fluidcollection device (e.g., a sample reservoir, a syringe, or other sourceof potential energy used to create negative pressure), as describedabove with reference to the housing 130. In some instances, it may bedesirable to modulate and/or control a magnitude of the negativepressure differential. In the embodiment shown in FIGS. 2-5 , forexample, the housing 230 defines a restricted flow path 232 that placesthe flow controller 242 in fluid communication with the fluid flow path254. More specifically, the restricted flow path 232 is a fluid flowpath having a smaller diameter than at least the fluid flow path 254.

For example, in some embodiments, the restricted flow path 232 can havea diameter of about 0.0005″, about 0.001″, about 0.003″, about 0.005″,about 0.01″, about 0.1″, about 0.5″ or more. In other embodiments, therestricted flow path 232 can have a diameter less than 0.0005″ orgreater than 0.5″. In some embodiments, the restricted flow path 232 canhave a predetermined and/or desired length of about 0.01″, about 0.05″,about 0.1″, about 0.15″, about 0.2″, about 0.5″, or more. In otherembodiments, the restricted flow path 232 can have a predeterminedand/or desired length that is less than 0.01″ or more than about 0.5″.Moreover, in some embodiments, a restricted flow path 232 can have anysuitable combination of diameter and length to allow for and/or toprovide a desired flow characteristic through at least a portion of thecontrol device 200.

In this embodiment, the restricted flow path 232 having a smallerdiameter results in a lower magnitude of negative pressure being appliedthrough the sequestration chamber than a magnitude of negative pressurewhen the restricted flow path has a larger diameter. In some instances,modulating a magnitude of negative pressure can control a rate at whichbodily fluid is transferred into the sequestration chamber 234. Forexample, in some embodiments, a fluid collection device and/or othersuitable negative pressure source may produce a negative pressuredifferential having a magnitude (e.g., a negative magnitude) of about0.5 pounds per square inch (PSI), about 1.0 PSI, about 2.0 PSI, about3.0 PSI, about 4.0 PSI, about 5.0 PSI, about 10 PSI, about 12.5 PSI, orabout 14.7 PSI (e.g., at or substantially at atmospheric pressure atabout sea level). In some embodiments, a fluid collection device such asan evacuated container or the like can have a predetermined negativepressure of about 12.0 PSI. Accordingly, by controlling the diameterand/or length of the restricted flow path 232, the amount of negativepressure to which the sequestration chamber 234 is exposed and/or therate at which the negative pressure is applied can be controlled,reduced, and/or otherwise modulated. In some instances, the use of therestricted flow path 232 can result in a delay or ramp up of thenegative pressure exerted on or in the sequestration chamber.

Moreover, in this embodiment, the restricted flow path 232 is, forexample, a gas flow path configured to receive a flow of gas or air butnot a flow of a liquid (e.g., bodily fluid). In some embodiments, thediameter of the restricted flow path 232 can be sufficiently small tolimit and/or prevent a flow of a liquid therethrough. In addition, thearrangement of the restricted flow path 232 being disposed between thefluid flow path 254 and the flow controller 242 is such that a flow ofbodily fluid and/or any other liquid is substantially prevented by theflow controller 242 (e.g., a selectively permeable barrier or seal).

Although the pressure modulation is described above as being based on adiameter of the restricted flow path 232 (i.e., a single restricted flowpath), it should be understood that this is presented by way of exampleonly and not limitation. Other means of modulating the magnitude ofnegative pressure to which the sequestration chamber is exposed caninclude, for example, a porous material, a valve, a membrane, adiaphragm, a specific restriction, a vent, a deformable member or flowpath, and/or any other suitable means. In other embodiments, a controldevice can include any suitable number of restricted flow paths, each ofwhich can have substantially the same diameter or can have varieddiameters. For example, in some embodiments, a control device caninclude up to 100 restricted flow paths or more. In such embodiments,each of the restricted flow paths can have a diameter of between about0.0005″ and about 0.1″, between about 0.0005″ and about 0.05″, orbetween about 0.0005″ and about 0.01″. In some embodiments, multiplerestricted flow paths can be configured to (1) selectively provide aflow path between the outlet 236 and the sequestration chamber 234 thatexposes the sequestration chamber 234 to the negative pressuredifferential, and (2) act as a flow controller configured to selectivelyallow the passage of a gas and/or air while substantially preventing thepassage of a liquid (e.g., bodily fluid).

In some embodiments, modulating and/or controlling a magnitude of thepressure to which the sequestration chamber 234 is exposed can, in turn,modulate a magnitude of pressure exerted on the bodily fluid and/orwithin a vein of a patient. In some instances, such pressure modulationcan reduce, for example, hemolysis of a blood sample and/or a likelihoodof collapsing a vein. In some instances, the ability to modulate and/orcontrol an amount or magnitude of negative pressure can allow thecontrol device 200 to be used across a large spectrum of patients thatmay have physiological challenges whereby negative pressure is oftenneeded to facilitate collection of bodily fluid such as, for example,blood (i.e. pressure differential between atmospheric pressure and apatient's vascular pressure is not sufficient to facilitate consistentand sufficiently forceful flow) but not so much pressure that a rapidforce flattens, collapses, caves-in, and/or otherwise inhibits patencyand ability to collect blood.

The initial portion and/or amount of bodily fluid can be any suitablevolume of bodily fluid, as described in detail above with reference tothe control device 100. For example, in some instances, the initialvolume can be associated with and/or at least partially based on anamount or volume of bodily fluid that is sufficient to fully wet orsaturate the flow controller 242. In other words, in some embodiments,the initial volume of bodily fluid can be a volume sufficient totransition the flow controller 242 to a second state (e.g., a saturatedor fully wetted state). In some embodiments, the flow controller 242 isplaced in a sealed configuration when transitioned to the second state.That is to say, saturating and/or fully wetting the flow controller 242(e.g., the semi-permeable material) places the flow controller 242 in asealed configuration in which the flow controller 242 substantiallyprevents a flow of a liquid and a gas therethrough. Thus, transitioningthe flow controller 242 to the second state sequesters, blocks,isolates, separates, segregates, and/or otherwise prevents flow throughthe flow controller 242 between the restricted flow path 232 and thesequestration chamber 234.

After the initial volume of bodily fluid is transferred and/or divertedinto the sequestration chamber 234, the control device 200 and/or thehousing 230 can be transitioned to its second state or operating mode tosequester, segregate, retain, contain, isolate, etc. the initial volumein the sequestration chamber 234. For example, as described above, theflow controller 242 is placed in the sealed configuration. In addition,the actuator 250 can be actuated to transition from its first state toits second state to establish fluid communication between the fluid flowpaths 233 and 254. As such, the negative pressure otherwise exerted onor through the sequestration chamber 234 is now exerted on or throughthe fluid flow paths 233 and 254. In response, bodily fluid can flowfrom the inlet 231, through the fluid flow paths 233 and 254, throughthe outlet 236, and into the fluid collection device. In someembodiments, the transitioning of the flow controller 242 and theactuator 250 from their respective first states to their respectivesecond states is operable to sequester and/or retain the initial portionof the bodily fluid in the sequestration chamber 234. As described infurther detail herein, in some instances, contaminants such as, forexample, dermally residing microbes or the like dislodged during thevenipuncture event, can be entrained and/or included in the initialvolume of the bodily fluid and thus, are sequestered in thesequestration chamber 234 when the initial volume is sequesteredtherein.

With the fluid collection device fluidically coupled to the outlet 236and with the control device 200 and/or the housing 230 being in thesecond state (e.g., the initial volume of bodily fluid is sequestered inor by the sequestration chamber 234), any subsequent volume(s) of thebodily fluid can flow from the inlet 231, through the fluid flow paths233 and 254, through the outlet 236, and into the fluid collectiondevice. Thus, as described above, sequestering the initial volume ofbodily fluid in the sequestration chamber 234 prior to collecting orprocuring one or more sample volumes of bodily fluid reduces and/orsubstantially eliminates an amount of contaminants in the one or moresample volumes. Moreover, in some embodiments, the arrangement of thecontrol device 200 and/or the housing 230 can be such that the controldevice 200 and/or the housing 230 cannot transition to the second stateprior to collecting and sequestering the initial volume in thesequestration chamber 234.

While the control device 200 is described above with reference to FIGS.2-5 as including the actuator 250 configured to be moved (e.g., via aforce applied by a user) between the first state and the second state,in other embodiments, a control device can include any suitable member,device, mechanism, etc. configured to selectively establish fluidcommunication between two or more fluid flow paths. For example, FIGS.6-8 illustrate a fluid control device 300 according to an embodiment.The fluid control device 300 can be similar in at least form and/orfunction to the fluid control device 100 described above with referenceto FIG. 1 and/or the fluid control device 200 described above withreference to FIGS. 2-5 . Accordingly, portions of the fluid controldevice 300 that can be similar to portions of the fluid control devices100 and/or 200 are not described in further detail herein.

As shown in FIGS. 6-8 , the fluid control device 300 (also referred toherein as “control device” or “device”) includes a housing 330 having aninlet 331 and an outlet 336, and including or being coupled to anactuator 350. As described above with reference to the control devices100 and/or 200, the inlet 331 is configured to be placed in fluidcommunication with a bodily fluid source to receive a flow of bodilyfluid therefrom (e.g., via a lumen-containing device such as a needle orthe like). The outlet 336 is configured to be fluidically coupled to afluid collection device (not shown in FIGS. 6-8 ).

As described above with reference to the housings 130 and/or 230, thehousing 330 defines one or more fluid flow paths 333, 354A, and 354Bconfigured to selectively place the inlet 331 in fluid communicationwith the sequestration chamber 334 and/or the outlet 336. The housing330 of the device 300 can be any suitable shape, size, and/orconfiguration. For example, in some embodiments, the housing 330 can besubstantially similar in at least form and/or function to the housings130 and/or 230 described above. In some embodiments, the housing 330 canhave a size that is at least partially based on a volume of bodily fluidat least temporarily stored, for example, in the sequestration chamber334. The sequestration chamber 334 of the housing 330 is at leasttemporarily placed in fluid communication with the inlet 331 via thefluid flow path(s) 333. Moreover, the sequestration chamber 334 can beselectively placed in fluid communication with the fluid flow path 354Asuch that at least air or gas can be transferred therebetween, asdescribed in further detail herein.

As described in further detail herein, the sequestration chamber 334 isconfigured to (1) receive a flow and/or volume of bodily fluid from theinlet 331 and (2) sequester (e.g., separate, segregate, contain, retain,isolate, etc.) the flow and/or volume of bodily fluid therein. Thesequestration chamber 334 can have any suitable shape, size, and/orconfiguration. For example, in some embodiments, the sequestrationchamber 334 can be substantially similar to the sequestration chamber234 described above with reference to FIGS. 2-5 and thus, is notdescribed in further detail herein. Likewise, the housing 330 and/or thesequestration chamber 334 include, form, and/or define a flow controller342 that can be substantially similar to the flow controller 242described above. As such, the flow controller 342 is positioned withinthe housing 330 to selectively establish fluid communication between thesequestration chamber 334 and the fluid flow path 354A, as described infurther detail herein.

The outlet 336 of the housing 330 is in fluid communication with and/oris configured to be placed in fluid communication with the fluid flowpaths 333, 354A, and/or 354B. In addition, the outlet 336 is configuredto be fluidically coupled to a fluid collection device such as, forexample, a sample reservoir, container, vial, negative pressure source,syringe, and/or intermediate control and/or transfer device (not shownin FIGS. 6-8 ). The outlet 336 and the fluid collection device can eachbe substantially similar to the outlet 236 and fluid collection device,respectively, described above with reference to the control device 200.Thus, the outlet 336 and fluid collection device are not described infurther detail herein.

As shown in FIGS. 6-8 , the housing 330 includes and/or is coupled tothe actuator 350, which is configured to selectively control a flow ofbodily fluid through the housing 330. In some embodiments, the actuator350 can be substantially similar in at least function to the actuator250 described above with reference to FIGS. 2-5 . In this embodiment,however, the actuator 350 is arranged as a plunger and includes a set ofseals 365 disposed along an outer surface of the plunger. Moreover, theactuator 350 has a substantially annular shape and is configured to atleast temporarily receive and/or otherwise be disposed about a portionof the flow controller 342, as shown in FIG. 8 . As described above withreference to the actuator 250, the actuator 350 is configured toisolate, sequester, separate, and/or otherwise prevent fluidcommunication between the fluid flow path 333 and the fluid flow path354B when in the first state and is configured to place the fluid flowpath 333 in fluid communication with the fluid flow path 354B when inthe second state.

As described above, the device 300 can be used to procure a bodily fluidsample having reduced contamination from microbes such as, for example,dermally residing microbes, and/or the like. For example, in someinstances, a user such as a doctor, physician, nurse, phlebotomist,technician, etc. can manipulate the device 300 to establish fluidcommunication between the inlet 331 and the bodily fluid source (e.g., avein of a patient). Once the inlet 331 is placed in fluid communicationwith the bodily fluid source (e.g., the portion of the patient), theoutlet 336 can be fluidically coupled to the fluid collection device. Asdescribed above, in the embodiment shown in FIGS. 6-8 , the fluidcollection device can be, for example, an evacuated reservoir, asyringe, and/or any container that defines a negative pressure.

Coupling the outlet 336 to the fluid collection device selectivelyexposes at least a portion of the fluid flow paths 354A and 354B to thenegative pressure within and/or produced by the fluid collection device.The arrangement of the actuator 350 when in its first state,configuration, and/or position is such that the actuator 350 isolatesthe fluid flow path 354B from the fluid flow path 333 and as such, thefluid flow path 333 is not exposed to the negative pressure differentialproduced by the fluid collection device. As described above, the flowcontroller 342 is in fluid communication with the fluid flow path 354Aand the sequestration chamber 334. More particularly, the annulararrangement of the actuator 350 allows the flow controller 342 to be influid communication with the fluid flow path 354A (see e.g., FIG. 8 ).Thus, coupling the outlet 336 to the fluid collection device exposes thesequestration chamber 334 to the negative pressure of the fluidcollection device, thereby resulting in a negative pressure differentialoperable in drawing bodily fluid from the bodily fluid source (e.g., thepatient), through the inlet 331, and into the housing 330. As describedabove with reference to the control devices 100 and 200, the arrangementof the housing 330 is such that when a volume of bodily fluid istransferred to and/or through the inlet 331, an initial portion of thevolume of bodily fluid (also referred to herein as an “initial volume”or a “first volume”) flows from the inlet 331 and into the sequestrationchamber 334. That is to say, in some embodiments, the housing 330 can bein first or initial state in which the initial portion or volume ofbodily fluid can flow from the inlet 331 and into the sequestrationchamber 334.

As described above, the housing 330 and/or the control device 300 can bein the initial state when the flow controller 342 and the actuator 350are in a first state, position, configuration, etc. As such, theactuator 350 isolates, separates, segregates, sequesters and/orotherwise prevents direct fluid communication between the fluid flowpaths 333 and 354B. In addition, the inlet 331 is exposed to thenegative pressure differential via the sequestration chamber 334. Inother words, the negative pressure within or produced by the fluidcollection device can result in a negative pressure (or negativepressure differential) within at least a portion of the sequestrationchamber 334 that is operable in drawing an initial flow of bodily fluidfrom the inlet 331 into the sequestration chamber 334 when the housing330 and/or control device 300 is in the first or initial state. Asdescribed in detail above, in some instances, it may be desirable tomodulate and/or control a magnitude of the negative pressuredifferential by any suitable means such as those described herein.

The initial portion and/or amount of bodily fluid can be any suitablevolume of bodily fluid, as described in detail above with reference tothe control devices 100 and/or 200. For example, in some instances, theinitial volume can be associated with and/or at least partially based onan amount or volume of bodily fluid that is sufficient to fully wet orsaturate the flow controller 342. In other words, in some embodiments,the initial volume of bodily fluid can be a volume sufficient totransition the flow controller 342 to a second state (e.g., a saturatedor fully wetted state). As described above with reference to the flowcontroller 242, the flow controller 342 is placed in a sealedconfiguration when transitioned to the second state. Thus, transitioningthe flow controller 342 to the second state sequesters, blocks,isolates, separates, segregates, and/or otherwise prevents flow throughthe flow controller 342.

After the initial volume of bodily fluid is transferred and/or divertedinto the sequestration chamber 334, the control device 300 and/or thehousing 330 can be transitioned to its second state or operating mode tosequester, segregate, retain, contain, isolate, etc. the initial volumein the sequestration chamber 334. As described above, the flowcontroller 342 is placed in the sealed configuration and thus,substantially prevents a flow of fluid therethrough. In this embodiment,the arrangement of the actuator 350 is such that when the flowcontroller 342 is placed in the sealed configuration, at least a portionof the negative pressure otherwise being exerted through the flowcontroller 342 is instead exerted on the actuator 350, which in turn, issufficient to transition the actuator 350 from its first state to itssecond state. For example, in some embodiments, the negative pressure isoperable to move the actuator 350 from a first position (e.g., the firststate) to a second position (e.g., the second state), therebyestablishing fluid communication between the fluid flow paths 333 and354B.

More particularly, moving the actuator 350 to its second position (orotherwise transitioning the actuator 350 to its second state), movesand/or transitions the seals 365 relative to the fluid flow paths 333and 354B such that fluid communication is established therebetween. Assuch, the negative pressure otherwise exerted on or through thesequestration chamber 334 is now exerted on or through the fluid flowpaths 333 and 354B. In response, bodily fluid can flow from the inlet331, through the fluid flow paths 333 and 354B, through the outlet 336,and into the fluid collection device. In some embodiments, thetransitioning of the flow controller 342 and the actuator 350 from theirrespective first states to their respective second states is operable tosequester and/or retain the initial portion of the bodily fluid in thesequestration chamber 334. As described in further detail herein, insome instances, contaminants such as, for example, dermally residingmicrobes or the like dislodged during the venipuncture event, can beentrained and/or included in the initial volume of the bodily fluid andthus, are sequestered in the sequestration chamber 334 when the initialvolume is sequestered therein.

With the fluid collection device fluidically coupled to the outlet 336and with the control device 300 and/or the housing 330 being in thesecond state (e.g., the initial volume of bodily fluid is sequestered inor by the sequestration chamber 334), any subsequent volume(s) of thebodily fluid can flow from the inlet 331, through the fluid flow paths333 and 354B, through the outlet 336, and into the fluid collectiondevice. Thus, as described above, sequestering the initial volume ofbodily fluid in the sequestration chamber 334 prior to collecting orprocuring one or more sample volumes of bodily fluid reduces and/orsubstantially eliminates an amount of contaminants in the one or moresample volumes. Moreover, in some embodiments, the arrangement of thehousing 330 can be such that housing 330 cannot transition to the secondstate prior to collecting and sequestering the initial volume in thesequestration chamber 334.

FIGS. 9 and 10 illustrate a fluid control device 400 according to anembodiment. The fluid control device 400 can be similar in at least formand/or function to the fluid control device 100 described above withreference to FIG. 1 , the fluid control device 200 described above withreference to FIGS. 2-5 , and/or the fluid control device 300 describedabove with reference to FIGS. 6-8 . Accordingly, portions of the fluidcontrol device 400 that can be similar to portions of the fluid controldevices 100, 200, and/or 300 are not described in further detail herein.

As shown in FIGS. 9 and 10 , the fluid control device 400 (also referredto herein as “control device” or “device”) includes a housing 430 havingan inlet 431 and an outlet 436, and having and/or being coupled to anactuator 450. As described above with reference to the control devices100, 200, and/or 300, the inlet 431 is configured to be placed in fluidcommunication with a bodily fluid source to receive a flow of bodilyfluid therefrom (e.g., via a lumen-containing device such as a needle orthe like). The outlet 436 is configured to be fluidically coupled to afluid collection device (not shown in FIGS. 9 and 10 ).

As described above, the housing 430 of the control device 400 isconfigured to (1) receive a flow and/or volume of bodily fluid via theinlet 431 and (2) sequester (e.g., separate, segregate, contain, retain,isolate, etc.) the flow and/or volume of bodily fluid within thesequestration chamber 434. The housing 430 can be any suitable shape,size, and/or configuration. In some embodiments, the housing 430 canhave a size that is at least partially based on a volume of bodily fluidat least temporarily stored, for example, in the sequestration chamber434. For example, in the embodiment shown in FIGS. 9 and 10 , thehousing 430 is arranged (at least in part) as a syringe-like device orthe like, as described in further detail herein.

The housing 430 defines fluid flow paths 433 and 454 that areselectively in fluid communication with the outlet 436 and thatselectively receive a flow of fluid therethrough (e.g., a liquid and/ora gas). The outlet 436 of the housing 430 is in fluid communication withand/or is configured to be placed in fluid communication with the fluidflow paths 433 and/or 454. In addition, the outlet 436 is configured tobe fluidically coupled to a fluid collection device (not shown in FIGS.9 and 10 ). The outlet 436 and the fluid collection device can each besubstantially similar to the outlet 236 and fluid collection device,respectively, described above with reference to the control device 200.Thus, the outlet 436 and fluid collection device are not described infurther detail herein.

The housing 430 includes and/or is coupled to the actuator 450configured to selectively control a flow of bodily fluid through thehousing 430. In this embodiment, the actuator 450 includes a firstplunger 460 and a second plunger 461 movably disposed within the housing430 and configured to at least partially define the sequestrationchamber 434. More specifically, the actuator 450 is configured to movebetween a first state in which the inlet 431 is placed in fluidcommunication with the sequestration chamber 434 (FIG. 9 ) and a secondstate in which the inlet 431 is placed in fluid communication with theoutlet 436 via the fluid flow path 454 (FIG. 10 ). In this embodiment,when the actuator 450 and/or housing 430 is in the first state, theinlet 431 is in fluid communication with a portion of the housing 430defined between the first plunger 460 and the second plunger 461.

When in the first state, the first plunger 460 is disposed in a positionsuch that a dampening chamber 437 is defined by the housing 430 on aside of the first plunger 460 opposite the sequestration chamber 434. Asshown, the dampening chamber 437 is configured to be placed in fluidcommunication with the fluid flow path 433 via a port 435. The port 435can be an opening, a valve, a membrane, a diaphragm, and/or any othersuitable flow controller or the like configured to at least selectivelyestablish fluid communication between the fluid flow path 433 and thedampening chamber 437. Furthermore, when the actuator 450 and/or thehousing 430 is in the first state, the dampening chamber 437 includesand/or contains a dampening fluid 456 such as a gas (compressed oruncompressed) and/or a liquid (e.g., water, oil, dampening fluid, and/orany other suitable liquid).

When the actuator 450 and/or housing 430 are in the first state, thesecond plunger 461 is disposed in a position within the housing 430 suchthat one or more seals 465 formed by or coupled to the second plunger461 fluidically isolate, separate, and/or sequester the inlet 431 fromthe fluid flow path 454. In addition, the second plunger 461 and/or theseals 465 formed by or coupled thereto fluidically isolate the fluidflow path 454 from the sequestration chamber 434. Thus, when theactuator 450 and/or control device 400 are in the first state, the inlet431 is in fluid communication with the sequestration chamber 434 and isfluidically isolated from the fluid flow paths 433 and 454 as well asthe outlet 436 (see FIG. 9 ). As described in further detail herein, theactuator 450 and/or the control device 400 can be configured totransition to the second state in which the sequestration chamber 434 issequestered within the housing 430 and the inlet 431 is placed in fluidcommunication with the fluid flow path 454 (see FIG. 10 ).

As described above, the device 400 can be used to procure a bodily fluidsample having reduced contamination from microbes such as, for example,dermally residing microbes, and/or the like. For example, in someinstances, a user such as a doctor, physician, nurse, phlebotomist,technician, etc. can manipulate the device 400 to establish fluidcommunication between the inlet 431 and the bodily fluid source (e.g., avein of a patient). Once the inlet 431 is placed in fluid communicationwith the bodily fluid source (e.g., the portion of the patient), theoutlet 436 can be fluidically coupled to the fluid collection device. Asdescribed above, in the embodiment shown in FIGS. 9 and 10 the fluidcollection device can be, for example, an evacuated reservoir orcontainer that defines a negative pressure.

As shown in FIG. 9 , the actuator 450 and/or the control device 400 canbe in a first or initial state prior to coupling the outlet 436 to thefluid collection device. Thus, the fluid flow path 433 is in fluidcommunication with the dampening chamber 437 and the fluid flow path 454is fluidically isolated from the inlet 431 and the sequestration chamber434 (e.g., via the second plunger 461). As described above, coupling theoutlet 436 to the fluid collection device exposes at least a portion ofthe fluid flow paths 433 and 454 to the negative pressure within thefluid collection device. When the actuator 450 and/or the control device400 are in the first state, the second plunger 461 isolates the housing430 and/or the sequestration chamber 434 from the negative pressureexerted via the fluid flow path 454. Conversely, the negative pressureexerted through the fluid flow path 433 can be operable in exerting atleast a portion of the negative pressure on the dampening chamber 437(e.g., via the port 435). In some embodiments, for example, the port 435can be transitioned from a closed configuration to an open configurationin response to the negative pressure.

The negative pressure exerted through the fluid flow path 433 isoperable in transitioning the actuator 450 from a first state to asecond state. For example, in some embodiments, the negative pressuredifferential draws the dampening fluid 456 from the dampening chamber437 and into the fluid flow path 433 or a secondary chamber or the like.Moreover, the negative pressure urges the first plunger 460 totransition and/or move relative to the housing 430 from a firstconfiguration or position to a second configuration or position. In someembodiments, the transitioning and/or moving of the first plunger 460can be such that a volume of the housing 430 defined between the firstplunger 460 and the second plunger 461 is increased (i.e., a volume ofthe sequestration chamber 434 is increased). In some embodiments, theincrease in the volume of the sequestration chamber 434 results in anegative pressure therein, which in turn, can be operable in drawing aninitial volume of bodily fluid through the inlet 431 and into thesequestration chamber 434. In other words, the negative pressure of thefluid collection device indirectly results in a negative pressuredifferential between the inlet 431 and the sequestration chamber 434that is operable in drawing the initial volume of bodily fluid into thesequestration chamber 434.

As shown in FIG. 10 , movement of the first plunger 460 results in asimilar movement of the second plunger 461. For example, in someembodiments, the arrangement of the actuator 450 is such that after thefirst plunger 460 has moved a predetermined amount (and/or after thevolume of the sequestration chamber 434 has been increased apredetermined amount) and an initial volume of bodily fluid has beendrawn into the sequestration chamber 434, the second plunger 461 ismoved or transitioned from a first position and/or configuration to asecond position and/or configuration. As such, the actuator 450 isplaced in its second state in which the sequestration chamber 434 issequestered from the inlet 431. In addition, the second plunger 461and/or the seals 465 coupled thereto place the inlet 431 in fluidcommunication with the fluid flow path 454. Thus, the negative pressureotherwise exerted on or through the fluid flow path 433 is now exertedon or through the fluid flow path 454. In response, bodily fluid canflow from the inlet 431, through the fluid flow path 454, through theoutlet 436, and into the fluid collection device.

In some embodiments, the transitioning of the actuator 450 from thefirst state to the second state is operable to sequester and/or retainthe initial portion of the bodily fluid in the sequestration chamber434. As described in further detail herein, in some instances,contaminants such as, for example, dermally residing microbes or thelike dislodged during the venipuncture event, can be entrained and/orincluded in the initial volume of the bodily fluid and thus, aresequestered in the sequestration chamber 434 when the initial volume issequestered therein. Thus, as described above, sequestering the initialvolume of bodily fluid in the sequestration chamber 434 prior tocollecting or procuring one or more sample volumes of bodily fluidreduces and/or substantially eliminates an amount of contaminants in theone or more sample volumes. Moreover, in some embodiments, thearrangement of the housing 430 can be such that housing 430 cannottransition to the second state prior to collecting and sequestering theinitial volume in the sequestration chamber 434.

As described above with reference to the control devices 100, 200,and/or 300, the control device 400 is configured to modulate an amountof negative pressure exerted on the first plunger 460 when the actuator450 is in the first state. Specifically, in this embodiment, thedampening fluid 456 disposed in the dampening chamber 437 reduces amagnitude of the negative pressure exerted on the first plunger 460. Assuch, the rate at which the actuator 450 and/or control device 400 istransitioned from the first state to the second state can be controlled.Moreover, in some instances, exposing the housing 430 to the fullmagnitude of the negative pressure may result transitioning the actuator450 and/or the control device 400 from the first state to the secondstate prior to receiving the initial volume of bodily fluid in thesequestration chamber 434. Thus, modulating the magnitude of thepressure can ensure a desired volume of bodily fluid is transferred intothe sequestration chamber 434. Although shown in FIGS. 9 and 10 asmodulating the negative pressure via the dampening fluid 456, it shouldbe understood that this is presented by way of example only and notlimitation. Any other suitable means of dampening and/or modulating amagnitude of the negative pressure can be used to control thetransitioning of the actuator 450 and/or housing 430.

Although the housing 430 is shown in FIGS. 9 and 10 and described aboveas including the plungers 460 and 461 and being in a syringe-likeconfiguration, in other embodiments, a housing can include any othersuitable means for controlling fluid flow therethrough. For example,FIGS. 11 and 12 illustrate a fluid control device 500 according to anembodiment. The fluid control device 500 can be similar in at least formand/or function to any of the fluid control devices 100, 200, 300,and/or 400. Accordingly, portions of the fluid control device 500 thatcan be similar to portions of the fluid control devices 100, 200, 300,and/or 400 are not described in further detail herein. As shown in FIGS.11 and 12 , the fluid control device 500 (also referred to herein as“control device” or “device”) includes a housing 530 having an inlet 531and an outlet 536, and having and/or being coupled to an actuator 550.As described above with reference to the control devices 100, 200, 300,and/or 400, the inlet 531 is configured to be placed in fluidcommunication with a bodily fluid source to receive a fluid of bodilyfluid therefrom (e.g., via a lumen-containing device such as a needle orthe like). The outlet 536 is configured to be fluidically coupled to afluid collection device (not shown in FIGS. 11 and 12 ). The inlet 531,the outlet 536, and the fluid collection device can be substantiallysimilar to those described above and thus, are not described in furtherdetail herein.

As described above, the housing 530 of the control device 500 isconfigured to (1) receive a flow and/or volume of bodily fluid via theinlet 531 and (2) sequester (e.g., separate, segregate, contain, retain,isolate, etc.) the flow and/or volume of bodily fluid within thesequestration chamber 534. The housing 530 can be any suitable shape,size, and/or configuration. In some embodiments, the housing 530 canhave a size that is at least partially based on a volume of bodily fluidat least temporarily stored, for example, in the sequestration chamber534. For example, in the embodiment shown in FIGS. 11 and 12 , thehousing 530 can be arranged in a substantially similar manner as thehousing 430 described above with reference to FIGS. 9 and 10 . Asdescribed in further detail herein, the housing 530 can differ from thehousing 430, by arranging the actuator 550 as, for example, a diaphragmrather than one or more plungers.

The housing 530 defines a set of fluid flow paths 533 and 554 in fluidcommunication with the outlet 536 and configured to selectively receivea flow of fluid therethrough (e.g., a liquid and/or a gas). The housing530 includes and/or is coupled to the actuator 550 configured toselectively control a flow of bodily fluid through the housing 530. Inthis embodiment, the actuator 550 includes a diaphragm 576 movablydisposed within the housing 530 and configured to at least partiallydefine the sequestration chamber 534. More specifically, the actuator550 is configured to move between a first state in which the inlet 531is placed in fluid communication with the sequestration chamber 534(FIG. 11 ) and a second state in which the inlet 531 is placed in fluidcommunication with the outlet 536 via the fluid flow path 554 (FIG. 12).

As shown in FIG. 11 , when the actuator 550 and/or control device 500 isin the first state, the inlet 531 is in fluid communication with aportion of the housing 530 defined between the diaphragm 576 and one ormore seals 565. Moreover, the diaphragm 576 is disposed in a first statesuch that a dampening chamber 537 is defined by the housing 530 on aside of the diaphragm 576 opposite the sequestration chamber 534, asdescribed above with reference to the housing 430. As shown, thedampening chamber 537 is configured to be placed in fluid communicationwith the fluid flow path 533 via a port 535. The port 535 can be anopening, a valve, a membrane, a diaphragm, and/or any other suitableflow controller or the like configured to at least selectively establishfluid communication between the fluid flow path 533 and the dampeningchamber 537. Furthermore, when the actuator 550 and/or the controldevice 500 is in the first state, the dampening chamber 537 includesand/or contains a dampening fluid such as a gas (compressed oruncompressed) and/or a liquid (e.g., water, oil, dampening fluid, and/orany other suitable liquid). As described above with reference to thecontrol devices 400, the arrangement of the dampening chamber 537, thedampening fluid, and the port 535 can be configured to modulate anamount of negative pressure exerted on the diaphragm 576 when theactuator 550 is in the first state. Although shown in FIGS. 11 and 12 asmodulating the negative pressure via the dampening fluid, it should beunderstood that this is presented by way of example only and notlimitation. Any other suitable means of dampening and/or modulating amagnitude of the negative pressure can be used to control thetransitioning of the actuator 550 and/or the control device 500.

As described above with reference to the actuator 450, when the actuator550 and/or the control device 500 are in the first state, the one ormore seals 565 are disposed in a position within the housing 530 suchthat the one or more seals 565 fluidically isolate, separate, and/orsequester the inlet 531 from the fluid flow path 554. In addition, theone or more seals 565 fluidically isolate the fluid flow path 554 fromthe sequestration chamber 534. Thus, when the actuator 550 and/or thecontrol device 500 are in the first state, the inlet 531 is in fluidcommunication with the sequestration chamber 534 and fluidicallyisolated from the fluid flow paths 533 and 554 as well as the outlet 536(see FIG. 11 ). As described in further detail herein, the actuator 550and/or the control device 500 housing 530 can be configured totransition to the second state in which the sequestration chamber 534 issequestered within the housing 530 and the inlet 531 is placed in fluidcommunication with the fluid flow path 554 (see FIG. 12 ).

As described in detail above, the device 500 can be used to procure abodily fluid sample having reduced contamination from microbes such as,for example, dermally residing microbes, and/or the like. For example,in some instances, a user can place the inlet 531 in fluid communicationwith the bodily fluid source (e.g., the portion of the patient) and canfluidically couple the outlet 536 to the fluid collection device. Asshown in FIG. 11 , the actuator 550 and/or the device 500 can be in afirst or initial state prior to coupling the outlet 536 to the fluidcollection device. Thus, the fluid flow path 533 is in fluidcommunication with the dampening chamber 537 and the fluid flow path 554is fluidically isolated from the inlet 531 and the sequestration chamber534 (e.g., via the one or more seals 565), as described in detail abovewith reference to the control device 400 of FIGS. 9 and 10 .

Coupling the outlet 536 to the fluid collection device selectivelyexposes at least a portion of the fluid flow paths 533 and 554 to thenegative pressure within and/or produced by the fluid collection device.When the actuator 550 and/or the device 500 are in the first state, theone or more seals 565 isolate the housing 530 and/or the sequestrationchamber 534 from the negative pressure exerted via the fluid flow path554. Conversely, the negative pressure exerted through the fluid flowpath 533 can be operable in exerting at least a portion of the negativepressure on the dampening chamber 537 (e.g., via the port 535). In someembodiments, for example, the port 535 can be transitioned from a closedconfiguration to an open configuration in response to the negativepressure. The negative pressure exerted through the fluid flow path 533is operable in transitioning the actuator 550 from a first state to asecond state. For example, in some embodiments, the negative pressuredifferential draws the dampening fluid from the dampening chamber 537and into the fluid flow path 533. Moreover, the negative pressure urgesthe diaphragm 576 to transition, flip, move, switch, deform, etc., froma first configuration or state (FIG. 11 ) to a second configuration orstate (FIG. 12 ). As described above with reference to the actuator 450,the transitioning of the diaphragm 576 from the first state to thesecond state can be such that a volume of the housing 530 definedbetween the diaphragm 576 and the one or more seals 565 is increased(i.e., a volume of the sequestration chamber 534 is increased), which inturn, results in a negative pressure therein that can be operable indrawing an initial volume of bodily fluid through the inlet 531 and intothe sequestration chamber 534.

As shown in FIG. 12 , movement of the diaphragm 576 results in a similarmovement of the one or more seals 565 such that the one or more seals565 are disposed on the same side of the inlet 531 as the diaphragm 576.Thus, the sequestration chamber 534 is sequestered within the housing530. In addition, moving the one or more seals 565 is such that fluidcommunication is established between the inlet 531 and the fluid flowpath 554. Thus, the negative pressure otherwise exerted on or throughthe fluid flow path 533 is now exerted on or through the fluid flow path554. In response, bodily fluid can flow from the inlet 531, through thefluid flow path 554, through the outlet 536, and into the fluidcollection device, as described in detail above. In some embodiments,the transitioning of the actuator 550 from the first state to the secondstate is operable to sequester and/or retain the initial portion of thebodily fluid in the sequestration chamber 534, which can includecontaminants such as, for example, dermally residing microbes or thelike dislodged during the venipuncture event. Thus, as described above,sequestering the initial volume of bodily fluid in the sequestrationchamber 534 prior to collecting or procuring one or more sample volumesof bodily fluid reduces and/or substantially eliminates an amount ofcontaminants in the one or more sample volumes. Moreover, in someembodiments, the arrangement of the control device 500 and/or thehousing 530 can be such that the control device 500 and/or the housing530 cannot transition to the second state prior to collecting andsequestering the initial volume in the sequestration chamber 534.

FIGS. 13-15 illustrate a fluid control device 600 according to anembodiment. The fluid control device 600 can be similar in at least formand/or function to any of the fluid control devices 100, 200, 300, 400,and/or 500. Accordingly, portions of the fluid control device 600 thatcan be similar to portions of the fluid control devices 100, 200, 300,400, and/or 500 are not described in further detail herein. As shown inFIGS. 13-15 , the fluid control device 600 (also referred to herein as“control device” or “device”) includes a housing 630 having an inlet 631and an outlet 636, and having and/or being coupled to an actuator 650.As described above with reference to the control devices 100, 200, 300,500, and/or 500, the inlet 631 is configured to be placed in fluidcommunication with a bodily fluid source to receive a fluid of bodilyfluid therefrom (e.g., via a lumen-containing device such as a needle orthe like). The outlet 636 is configured to be fluidically coupled to afluid collection device (not shown in FIGS. 13-15 ). The inlet 631, theoutlet 636, and the fluid collection device can be substantially similarto those described above and thus, are not described in further detailherein.

As described above, the housing 630 of the control device 600 isconfigured to (1) receive a flow and/or volume of bodily fluid via theinlet 631 and (2) sequester (e.g., separate, segregate, contain, retain,isolate, etc.) the flow and/or volume of bodily fluid within asequestration chamber 634 included in and/or at least partially formedby the housing 630. The housing 630 can be any suitable shape, size,and/or configuration. In some embodiments, the housing 630 can have asize that is at least partially based on a volume of bodily fluid atleast temporarily stored, for example, in the sequestration chamber 634.For example, in the embodiment shown in FIGS. 13-15 , the housing 630can be arranged in a substantially similar manner as the housing 530described above with reference to FIGS. 11 and 12 . That is to say, thehousing 630 includes an actuator 650 that is arranged as a diaphragm.

The housing 630 defines a set of fluid flow paths 633 and 654 in fluidcommunication with the outlet 636 and configured to selectively receivea flow of fluid therethrough (e.g., a liquid and/or a gas). The housing630 includes and/or is coupled to the actuator 650 configured toselectively control a flow of bodily fluid through the housing 630. Inthis embodiment, the actuator 650 includes a diaphragm 676 movablydisposed within the housing 630 and configured to at least partiallydefine the sequestration chamber 634. More specifically, the actuator650 is configured to move between a first state in which the inlet 631is placed in fluid communication with the sequestration chamber 634 anda second state in which the inlet 631 is placed in fluid communicationwith the outlet 636 via the fluid flow path 654, as described in detailabove with reference to the control device 500.

As shown in FIGS. 14 and 15 , when the actuator 650 and/or the device600 is in the first state, the inlet 631 is in fluid communication witha portion of the housing 630 defined between the diaphragm 676 and oneor more seals 665. Moreover, the diaphragm 676 is disposed in a firststate such that a dampening chamber 637 is defined by the housing 630 ona side of the diaphragm 676 opposite the sequestration chamber 634, asdescribed above with reference to the housing 530. As shown, thedampening chamber 637 is configured to be placed in fluid communicationwith the fluid flow path 654 via a port 635 (such as those describedabove). Although not shown, when the actuator 650 and/or the device 600is in the first state, the dampening chamber 637 includes and/orcontains a dampening fluid such as a gas (compressed or uncompressed)and/or a liquid (e.g., water, oil, dampening fluid, and/or any othersuitable liquid), that can be configured to modulate an amount ofnegative pressure exerted on the diaphragm, as described in detail abovewith reference to the control device 500. Although described asmodulating the negative pressure via the dampening fluid, it should beunderstood that this is presented by way of example only and notlimitation. Any other suitable means of dampening and/or modulating amagnitude of the negative pressure can be used to control thetransitioning of the actuator 650 and/or device 600.

As described above with reference to the actuator 550, when the actuator650 and/or the device 600 are in the first state, the seal 665 isdisposed in a position within the housing 630 such that the seal 665fluidically isolates, separates, and/or sequesters the inlet 631 fromthe fluid flow path 654. In addition, the seal 665 fluidically isolatesthe fluid flow path 654 from the sequestration chamber 634. Thus, whenthe actuator 650 and/or the device 600 are in the first state, the inlet631 is in fluid communication with the sequestration chamber 634 andfluidically isolated from the fluid flow path 654 as well as the outlet636. The actuator 650 and/or the device 600 can be configured totransition to the second state in which the sequestration chamber 634 issequestered within the housing 630 and the inlet 631 is placed in fluidcommunication with the fluid flow path 654. Accordingly, the device 600can be used to procure a bodily fluid sample having reducedcontamination from microbes (e.g., dermally residing microbes and/or thelike), in a substantially similar manner as the device 500 describedabove with reference to FIGS. 11 and 12 . Thus, the functioning of thedevice 600 is not described in further detail herein.

FIGS. 16-18 illustrate a fluid control device 700 according to anembodiment. The fluid control device 700 can be similar in at least formand/or function to any of the fluid control devices 100, 200, 300, 400,500, and/or 600. Accordingly, portions of the fluid control device 700that can be similar to portions of the fluid control devices 100, 200,300, 400, 500, and/or 600 are not described in further detail herein. Asshown in FIGS. 16-18 , the fluid control device 700 (also referred toherein as “control device” or “device”) includes a housing 730 having aninlet 731 and an outlet 736, and having or being coupled to an actuator750. As described above with reference to the control devices 100, 200,300, 400, 500, and/or 600, the inlet 731 is configured to be placed influid communication with a bodily fluid source to receive a fluid ofbodily fluid therefrom (e.g., via a lumen-containing device such as aneedle or the like). The outlet 736 is configured to be fluidicallycoupled to a fluid collection device (not shown in FIGS. 16-18 ). Theinlet 731, the outlet 736, and the fluid collection device can besubstantially similar to those described above and thus, are notdescribed in further detail herein.

As described above, the housing 730 of the control device 700 isconfigured to (1) receive a flow and/or volume of bodily fluid via theinlet 731 and (2) sequester (e.g., separate, segregate, contain, retain,isolate, etc.) the flow and/or volume of bodily fluid within thesequestration chamber 734. The housing 730 can be any suitable shape,size, and/or configuration. In some embodiments, the housing 730 canhave a size that is at least partially based on a volume of bodily fluidat least temporarily stored, for example, in the sequestration chamber734. For example, in the embodiment shown in FIGS. 16-18 , the housing730 can be arranged in a substantially similar manner as the housings530 and/or 630. That is to say, the housing 530 includes and/or iscoupled to the actuator 750 that is arranged as a diaphragm.

The housing 730 defines a set of fluid flow paths 733 and 754 in fluidcommunication with the outlet 736 (see e.g., FIGS. 17A and 17B) andconfigured to selectively receive a flow of fluid therethrough (e.g., aliquid and/or a gas). The housing 730 includes and/or is coupled to theactuator 750 configured to selectively control a flow of bodily fluidthrough the housing 730. In this embodiment, the actuator 750 includes adiaphragm 776 movably disposed within the housing 730 and configured toat least partially define the sequestration chamber 734. Morespecifically, the actuator 750 is configured to move between a firststate in which the inlet 731 is placed in fluid communication with thesequestration chamber 734 and a second state in which the inlet 731 isplaced in fluid communication with the outlet 736 via the fluid flowpath 754, as described in detail above with reference to the controldevice 500.

In the embodiment shown in FIGS. 16-18 , when the actuator 750 and/orthe device 700 are in the first state, the inlet 731 is in fluidcommunication with the sequestration chamber 734 formed by a portion ofthe housing 730 defined between the diaphragm 776 and a flow controller742 (e.g., a selectively permeable fluid barrier or seal, and/or anyother flow controller such as any of those described above). Moreover,the diaphragm 776 is disposed in a first state such that the fluid flowpath 733 is in fluid communication with the sequestration chamber 734.As described above with reference to the actuator 550, when in theactuator 750 and/or device 700 are in the first state, the diaphragm 776and/or the seal 765 are disposed in a position within the housing 730such that the diaphragm 776 and/or the seal 765 fluidically isolate,separate, and/or sequester the inlet 731 from the fluid flow path 754.In addition, the diaphragm 776 and/or the seal 765 fluidically isolatethe fluid flow path 754 from the sequestration chamber 734. Thus, whenthe actuator 750 and/or the device 700 are in the first state, the inlet731 is in fluid communication with the sequestration chamber 734 andfluidically isolated from the fluid flow path 754.

As described above with reference to, for example, the control device200, when the actuator 750 and/or the device 700 are in the first state,a negative pressure differential within the sequestration chamber 734can result from the coupling of the fluid collection device to theoutlet 736. More specifically, the fluid flow path 733 can be in fluidcommunication with the outlet 736 and the flow controller 742. When theflow controller 742 is in a first state, the flow controller 742 canallow a gas or air to pass therethrough. Thus, the negative pressuredifferential within the sequestration chamber 734 can result from thecoupling of the fluid collection device to the outlet 736.

As shown in FIG. 18 , the actuator 750 and/or the device 700 can beconfigured to transition to the second state in which the sequestrationchamber 734 is sequestered within the housing 730 and the inlet 731 isplaced in fluid communication with the fluid flow path 754, as describedin detail above with reference to the control device 600. Moreparticularly, an initial volume of bodily fluid can be transferred intothe sequestration chamber 734, which in turn, can saturate, can wet,and/or otherwise can transition the flow controller 742 from the firstor open state to a second or closed state. In some embodiments, thetransitioning of the flow controller 742 from the first state to thesecond state is operable in isolating the fluid flow path 733 from theoutlet 736. As such, a negative pressure exerted through the fluid flowpath 754 can be operable in transitioning, switching, flipping, moving,deforming, and/or otherwise reconfiguring the diaphragm 776 such thatthe actuator 750 is placed in its second state. As such, the negativepressure of the fluid collection device can draw bodily fluid from theinlet 731, through the housing 730 (bypassing the sequestration chamber734), through the fluid flow path 754 and the outlet 736, and into thefluid collection device, as described in detail above. Accordingly, thedevice 700 can be used to procure a bodily fluid sample having reducedcontamination from microbes (e.g., dermally residing microbes and/or thelike), in a manner substantially similar to one or more of the controldevices 100, 200, 300, 400, 500, and/or 600 described in detail above.Thus, the functioning of the device 700 is not described in furtherdetail herein.

In some embodiments, any of the control devices 100, 200, 300, 400, 500,600, and/or 700 can be formed from any suitable components that can bemanufactured, assembled, sterilized, and packaged as an assembly orintegrated device. In such embodiments, a user can, for example, open apackaging containing such an assembly or integrated device and can usethe device as described above with reference to the control devices 100,200, 300, 400, 500, 600, and/or 700. In some embodiments, any of thecontrol devices can be monolithically formed in whole or at least inpart.

In some embodiments any of the control devices can be physicallycoupled, attached, formed, and/or otherwise mated to a fluid collectiondevice (e.g., a sample reservoir, a syringe, a blood culture bottle, acollection vial, a fluid transfer container, and/or any other suitablereservoir, collection device, and/or transfer device) during amanufacturing process. This can be done prior to sterilization so thecollection pathway(s) and connection interface(s) (e.g., where thecontrol device couples to the fluid collection device) maintain aclosed-system, mechanical diversion device within a sterile environmentthat is not subject to touch-point contamination from external sources.In this manner, in order for a user to transfer a sample volume to thefluid collection device, the user would be forced first to sequester,segregate, and/or isolate at least a portion of the initial bodily fluidvolume or flow. In some embodiments, the coupling, mating, and/orattachment of the fluid control device to the fluid collection devicecan be executed such that the control device can be removed (physicallydecoupled, removed with a specific “key,” and/or any other approach usedto separate the control device from the fluid collection device) afteruse to allow access to the fluid collection device, which can then beplaced in an incubator and/or any other type of analytical machine, andaccessed for analysis and/or otherwise further processed. In someembodiments, such decoupling may be blocked, limited, and/orsubstantially prevented prior to use and unblocked or allowed after use.In other embodiments, the fluid control device and the fluid collectiondevice can be permanently coupled and/or monolithically formed (at leastin part) to prevent such decoupling.

While described above as being coupled and/or assembled, for example,during manufacturing, in other embodiments, however, a control devicecan include one or more modular components that can be selected by auser based on a desired use, preference, patient, etc. In suchembodiments, the user can couple one or more modular components(packaged together or packaged separately) to form the desired fluidcontrol device. For example, FIGS. 19-25 illustrate a modular fluidcontrol device 800 according to an embodiment. The fluid control device800 can be similar in at least form and/or function to the fluid controldevices described herein. More specifically, portions of the fluidcontrol device 800 can be similar to and/or substantially the same ascorresponding portions of the fluid control device 200 described abovewith reference to FIGS. 2-5 . Accordingly, such portions of the fluidcontrol device 800 are not described in further detail herein.

The fluid control device 800 (also referred to herein as “controldevice” or “device”) includes a housing 830 and an actuator 850. Asdescribed above, the control device 800 can be at least partiallymonolithically formed or can be otherwise preassembled duringmanufacturing. In other embodiments, the control device 800 can be atleast partially modular such that a user can physically and fluidicallycouple the housing 830 and the actuator 850 to form the control device800. The housing 830 of the device 800 can be any suitable shape, size,and/or configuration. For example, in the embodiment shown in FIGS.19-25 , the housing 830 can be, for example, relatively thin andsubstantially rectangular. In some embodiments, portions of the housing830 can be substantially similar in at least form and/or function to thehousing 230 described above with reference to FIGS. 2-5 . Thus, whilesuch portions are identified, similar components, features, and/orfunctions are not described in further detail herein.

As shown in FIGS. 19 and 20 , the housing 830 forms and/or defines asequestration chamber 834 that is in selective fluid communication witha first port 845 and a second port 846. The first port 845 and thesecond port 846 are configured to be at least fluidically coupled to aportion of the actuator 850 to allow for selective fluid flow betweenthe housing 830 and the actuator 850. As described in further detailherein, the sequestration chamber 834 is configured (1) to receive aselective flow and/or volume of bodily fluid from a portion of theactuator 850 via the first port 845, and (2) to sequester (e.g.,separate, segregate, contain, retain, isolate, etc.) the flow and/orvolume of bodily fluid (e.g., an initial or first flow and/or volume ofbodily fluid or any portion thereof) within the sequestration chamber834. The sequestration chamber 834 can have any suitable shape, size,and/or configuration. For example, in some embodiments, thesequestration chamber 834 can have any suitable size, volume, and/orfluid capacity such as, for example, those described above withreference to the sequestration chamber 134. In the embodiment shown inFIGS. 19-25 , the sequestration chamber 834 can be, for example, a fluidflow path that extends through and/or that is defined by at least aportion of the housing 830. In some embodiments, the sequestrationchamber 834 can be substantially similar in at least form and/orfunction to the sequestration chamber 234 described above with referenceto FIGS. 2-5 and thus, is not described in further detail herein.

As shown in FIG. 20 , the housing 830 includes and/or defines a flowcontroller 842 and a restricted flow path 832. The flow controller 842can be, for example, a valve, membrane, diaphragm, restrictor, vent, aselectively permeable member, port, etc. configured to selectivelycontrol (at least in part) a flow of fluids into and/or out of thesequestration chamber 834 and/or any other suitable portion of thehousing 830. For example, the flow controller 842 can be a selectivelypermeable fluid barrier (e.g., a blood barrier) that includes and/or isformed of a porous material configured to selectively allow a flow ofgas therethrough but to prevent a flow of a liquid therethrough. In someembodiments, the flow controller 842 can be substantially similar to theflow controller 242 described in detail above with reference to FIGS.2-5 and thus, is not described in further detail herein.

As shown, the restricted flow path 832 defined by the housing 830 is influid communication with the second port 846 and is positioned betweenthe second port 846 and the flow controller 842 (or a portion of thehousing 830 receiving or housing the flow controller 842). As describedabove with reference to the restricted flow path 232 shown in FIGS. 2-5, the restricted flow path 832 is a fluid flow path having a smallerdiameter than, for example, one or more other flow paths defined by thehousing 830 and/or actuator 850. For example, in some embodiments, therestricted flow path 832 can have a diameter between about 0.0005″ toabout 0.5″ and can have a length between about 0.01″ and about 0.5″, asdescribed above with reference to the restricted flow path 232. Asdescribed above, the smaller diameter of the restricted flow path 832results in a lower magnitude of negative pressure being applied throughthe sequestration chamber 834 than a magnitude of negative pressure whenthe restricted flow path 832 has a larger diameter. In other words, therestricted flow path 832 can be configured to modulate an amount ofnegative pressure to which the sequestration chamber 834 is exposed. Insome instances, modulating the amount of negative pressure can control arate at which bodily fluid is transferred into the sequestration chamber834. Moreover, in this embodiment, the restricted flow path 832 is, forexample, a gas flow path configured to receive a flow of gas or air butnot a flow of a liquid (e.g., bodily fluid), which can allow for anegative pressure differential sufficient to successfully collect theinitial volume of bodily fluid and/or sufficient to transition at leasta portion of the control device 800 to a second state, while limitingand/or substantially preventing a portion of the initial or first volumeof bodily fluid from being drawn through the sequestration chamber 834and the second port 846.

As shown in FIGS. 19-24 , the actuator 850 includes a body 851 and anactuator rod 862. The body 851 of the actuator 850 includes an inlet 852and an outlet 853. The inlet 852 and the outlet 853 can be substantiallysimilar in at least form and/or function to the inlet 231 and the outlet236, respectively, described above with reference to FIGS. 2-5 . Thus,the inlet 852 is configured to be placed in fluid communication with abodily fluid source to receive a flow of bodily fluid therefrom (e.g.,via a lumen-containing device such as a needle, IV catheter, PICC line,or the like). The outlet 853 is configured to be fluidically coupled toa fluid collection device 880 such as, for example, a sample reservoir,a syringe, and/or other intermediary bodily fluid transfer device,adapter, or vessel (see e.g., FIG. 25 ) such as, for example, a transferdevice similar to those described in the '510 publication.

As shown in FIG. 21 , the body 851 of the actuator 850 includes and/ordefines a first port 858 and a second port 859. The first port 858 is influid communication with the inlet 852 and the second port 859 is influid communication with the outlet 853. In addition, the first port 858and the second port 859 are configured to be at least fluidicallycoupled to the first port 845 and the second port 846, respectively, ofthe housing 830. As described in further detail herein, the actuator 850can be transitioned between a first operating mode or state and a secondoperating mode or state to selectively control fluid flow through theports 858 and 859 of the actuator 850 and the ports 845 and 846 of thehousing 830, which in turn, can selectively control a flow of bodilyfluid into and/or out of the sequestration chamber 834 of the housing830.

In some embodiments, the arrangement of the ports 858 and 859 of theactuator 850 and the ports 845 and 846 of the housing 830 can allow forand/or otherwise can provide a means of physically coupling the housing830 to the actuator 850 as well as fluidically coupling the housing 830to the actuator 850. For example, in some embodiments, the ports 858 and859 of the actuator 850 and the ports 845 and 846 of the housing 830 canform a friction fit, a press fit, an interference fit, and/or the like.In other embodiments, the ports 858 and 859 of the actuator 850 can becoupled to the ports 845 and 846, respectively, of the housing 830 viaan adhesive, a mechanical fastener, an elastomeric coupling, a gasket,an o-ring(s), and/or any other suitable coupling means. In still otherembodiments, the ports 858 and 859 of the actuator 850 can be physicallyand fluidically coupled to the ports 845 and 846, respectively, of thehousing 830 via an intervening structure such as, for example, one ormore sterile, flexible tubing(s). As such, the device 800 can be and/orcan have, for example, a modular configuration in which the housing 830can be at least fluidically coupled to the actuator 850.

In some embodiments, such a modular arrangement can allow a user toselect a housing (or actuator) with one or more desired characteristicsbased on, for example, the intended purpose and/or use of the assembleddevice. In other embodiments, the modular arrangement can allow and/orfacilitate one or more components with desired characteristics to becoupled and/or assembled during manufacturing. For example, in someinstances, it may be desirable to select a housing that includes and/ordefines a sequestration chamber having a particular or desired volume.As a specific example, when the device is being used to procure bodilyfluid from a pediatric patient and/or a very sick patient (for example),it may be desirable to select a housing that defines and/or includes asequestration chamber with a smaller volume than may otherwise beselected when the device is being used to procure bodily fluid from aseemingly healthy adult patient. Accordingly, such a modular arrangementcan allow a user (e.g., a doctor, physician, nurse, technician,phlebotomist, etc.) to select a housing or an actuator having one ormore desired characteristics based on, for example, the intended use ofthe device. In other instances, the modular arrangement can allow orfacilitate assembly of a housing or an actuator having one or moredesired characteristics during manufacturing without making significantchanges to one or more manufacturing processes.

The actuator rod 862 of the actuator 850 is movably disposed within aportion of the body 851. The actuator rod 862 includes a first endportion 863 and a second end portion 864, at least one of which extendsbeyond the body 851 of the actuator 850 with the actuator rod 862 isdisposed within the body 851 (see e.g., FIGS. 23 and 24 ). A portion ofthe actuator rod 862 includes and/or is coupled to a set of seals 865.The seals 865 can be, for example, o-rings, elastomeric over-molds,proud or raised dimensions or fittings, and/or the like. The arrangementof the actuator 862 and the body 851 of the actuator 850 can be suchthat an inner portion of the seals 865 forms a fluid tight seal with asurface of the actuator rod 862 and an outer portion of the seals 865forms a fluid tight seal with an inner surface of the body 851. In otherwords, the seals 865 form one or more fluid tight seals between theactuator rod 862 and the inner surface of the body 851. As shown inFIGS. 23 and 24 , the actuator rod 862 includes and/or is coupled tothree seals 865 which form and/or define a first fluid flow path 833within the body 851 of the actuator 850 and a second fluid flow path 854within the body 851 of the actuator 850.

The actuator rod 862 is configured to be moved or transitioned relativeto the body 851 between a first position or configuration and a secondposition or configuration. For example, in some instances, a force canbe exerted on the first end portion 863 of the actuator rod 862 to placethe actuator rod 862 in its first position and/or configuration, asshown in FIG. 23 . The force exerted on the first end portion 863 of theactuator rod 862 can come from any suitable source. For example, a usercan create the force with his or her hand or finger, a syringe, apositive or negative pressure source, and/or any other external energysource. When in the first position and/or configuration, the inlet 852of the actuator 850 is in fluid communication with the first fluid flowpath 833 and the outlet 853 of the actuator 850 is in fluidcommunication with the second fluid flow path 854. In some instances, aforce can be exerted on the second end portion 864 of the actuator rod862 to place the actuator rod 862 in its second position and/orconfiguration, as shown in FIG. 24 . When in the second position and/orconfiguration, the inlet 852 and the outlet 853 of the actuator 850 areeach in fluid communication with the second fluid flow path 854 whilethe first fluid flow path is sequestered, isolated, and/or otherwise notin fluid communication with the inlet 852 and the outlet 853. Althoughnot shown, the first port 858 of the actuator 850 is in fluidcommunication with the first fluid flow path 833 and the second port 859of the actuator 850 is in fluid communication with the second fluid flowpath 854. As such, moving and/or transitioning the actuator rod 862 (orthe actuator 850 in general) between the first position and the secondposition can be operable in selectively controlling a flow of fluid(e.g., bodily fluid) between the inlet 852 of the actuator 850 and thehousing 830, or between the inlet 852 of the actuator 850 and the outlet853 of the actuator 850, as described in further detail herein.

As described above, the device 800 can be used to procure a bodily fluidsample having reduced contamination from microbes such as, for example,dermally residing microbes, microbes external to the bodily fluidsource, and/or the like. For example, in some instances, a user such asa doctor, physician, nurse, phlebotomist, technician, etc. canmanipulate the device 800 to establish fluid communication between theinlet 852 and the bodily fluid source (e.g., a vein of a patient). Oncethe inlet 852 is placed in fluid communication with the bodily fluidsource (e.g., the portion of the patient), the outlet 853 can befluidically coupled to the fluid collection device 880. In theembodiment shown in FIGS. 19-25 , the fluid collection device 880 canbe, for example, a syringe (as shown in FIG. 25 ), and/or any othersuitable container or device configured to define or produce a negativepressure or energy source.

As described in detail above with reference to, for example, the device200, coupling the outlet 853 to the fluid collection device 880selectively exposes at least a portion of the control device 800 to anegative pressure within and/or produced by the fluid collection device880. More specifically, in the embodiment shown in FIGS. 19-25 ,coupling the outlet 853 to the fluid collection device 880 exposes theoutlet 853 of the actuator 850 and the second fluid flow path 854 to thenegative pressure within and/or produced by the fluid collection device880. In addition, the second port 859 of the actuator 850 is in fluidcommunication with the second fluid flow path 854 and the second port846 of the housing 830. The second port 846 of the housing 830, in turn,is in selective fluid communication with the sequestration chamber 834via the flow controller 842 and the restricted flow path 832. Forexample, the device 800 and/or the flow controller 842 can be in a firstoperating state or mode in which the flow controller 842 allows a flowof gas (e.g., air) through the flow controller 842 while limiting and/orpreventing a flow of liquid (e.g., bodily fluid such as blood) throughthe flow controller 842. Thus, coupling the fluid collection device 880to the outlet 853 results in a negative pressure differential betweenthe fluid collection device 880 (and/or any suitable negative pressuresource) and the sequestration chamber 834.

As described above, the control device 800 can be in a first or initialstate when the flow controller 842 and/or the actuator 850 are in afirst state, position, configuration, etc. As such, the actuator rod 862can be in its first position and/or configuration in which the firstfluid flow path 833 is in fluid communication with the inlet 852. Inaddition, the first port 858 of the actuator 850 and the first port 845of the housing 830 establish fluid communication between thesequestration chamber 834 and the first fluid flow path 833. Thus, thenegative pressure within the fluid collection device 880 can result in anegative pressure (or negative pressure differential) within at least aportion of the sequestration chamber 834 that is operable in drawing aninitial flow, portion, amount, or volume of bodily fluid from the inlet852, through the first fluid flow path 833, and into the sequestrationchamber 834 when the actuator 850 and/or control device 800 is in thefirst or initial state (e.g., when the actuator rod 862 is in its firststate, position, and/or configuration). In some instances, thearrangement of the flow controller 842 and/or the restricted flow path832 can be configured to restrict, limit, control, and/or otherwisemodulate an amount or magnitude of negative pressure exerted on orthrough the sequestration chamber 834, as described in detail above withreference to the device 200.

The initial portion and/or amount of bodily fluid can be any suitablevolume of bodily fluid, as described in detail above with reference tothe control device 100. For example, in some instances, the initialvolume can be associated with and/or at least partially based on anamount or volume of bodily fluid that is sufficient to fully wet orsaturate the flow controller 842. In other words, in some embodiments,the initial volume of bodily fluid can be a volume sufficient totransition the flow controller 842 from a first state to a second state(e.g., a saturated or fully wetted state). In some embodiments, the flowcontroller 842 is placed in a sealed configuration when transitioned tothe second state. That is to say, saturating and/or fully wetting theflow controller 842 (e.g., the semi-permeable material) places the flowcontroller 842 in a sealed configuration in which the flow controller842 substantially prevents a flow of a liquid and a gas therethrough.Thus, transitioning the flow controller 842 to the second statesequesters, blocks, isolates, separates, segregates, and/or otherwiseprevents flow through the flow controller 842 between the restrictedflow path 832 and the sequestration chamber 834.

After the initial volume of bodily fluid is transferred and/or divertedinto the sequestration chamber 834, the control device 800 and/or theactuator 850 can be transitioned to its second state or operating modeto sequester, segregate, retain, contain, isolate, etc. the initialvolume in the sequestration chamber 834. For example, the actuator 850can be actuated to transition from its first state to its second state,for example, by exerting a force on the second end portion 864 of theactuator rod 862. As such, the actuator rod 862 is moved and/ortransitioned to its second state, position, and/or configuration inwhich the first fluid flow path 833 is sequestered and/or isolated fromthe inlet 852. With the flow controller 842 in the sealed configurationin response to the initial volume of bodily fluid being disposed in thesequestration chamber 834 and with the initial fluid flow path 833sequestered and/or isolated from the inlet 852, the initial volume ofbodily fluid is sequestered in the sequestration chamber 834. Asdescribed in detail above, in some instances, contaminants such as, forexample, dermally residing microbes or the like dislodged during thevenipuncture event, can be entrained and/or included in the initialvolume of the bodily fluid and thus, are sequestered in thesequestration chamber 834 when the initial volume is sequesteredtherein.

As shown in FIG. 24 , moving and/or transitioning the control device 800and/or the actuator 850 to its second state or configuration establishesfluid communication between the inlet 852 and the outlet 853 via thesecond fluid flow path 854. As such, the negative pressure otherwiseexerted on or through the sequestration chamber 834 is now exerted on orthrough the fluid flow path 854. In response, bodily fluid can flow fromthe inlet 852, through the fluid flow path 854, through the outlet 853,and into the fluid collection device 880. Thus, as described above,sequestering the initial volume of bodily fluid in the sequestrationchamber 834 prior to collecting or procuring one or more sample volumesof bodily fluid reduces and/or substantially eliminates an amount ofcontaminants in the one or more sample volumes. Moreover, in someembodiments, the arrangement of the control device 800 can be such thatthe control device 800 cannot transition to the second state prior tocollecting and sequestering the initial volume in the sequestrationchamber 834, thereby reducing the likelihood of contaminants beingtransferred to the fluid collection device 880.

In some instances, it may be desirable to isolate the negative pressuresource (e.g., the fluid collection device 880 from the inlet 853 suchas, for example, if it is desirable to collect multiple samples ofbodily fluid using multiple fluid collection device 880 (e.g.,syringes). For example, in some instances, after filling the fluidcollection device 880 the user can engage the actuator 850 and exert aforce on the first end portion 863 of the actuator rod 862 to moveand/or transition the actuator rod 862 from its second position and/orconfiguration toward its first position and/or configuration. As such,the second fluid flow path 854 no longer places the inlet 852 in fluidcommunication with the outlet 853. Moreover, the flow controller 842 canremain in the sealed state or configuration (e.g., fully saturated,wetted, and/or otherwise preventing flow therethrough) such that theoutlet 853 is substantially sequestered or isolated from the rest of thecontrol device 800. In some instances, the user can then remove thefilled fluid collection device 880 (e.g., syringe) and can couple a newfluid collection device 880 (e.g., syringe) to the outlet 853. With thenew fluid collection device 880 coupled to the outlet 853, the user can,for example, exert a force on the second end portion 864 of the actuatorrod 862 to move and/or transition the actuator rod 862 back to itssecond position, state, and/or configuration, as described above.

While the fluid collection device 880 coupled to the device 800 is shownin FIG. 25 as being a syringe, in other embodiments, a control devicecan be physically and/or fluidically coupled to any suitable collectiondevice. For example, FIG. 26 illustrates a fluid control device 900. Asdescribed above with reference to the control device 800, the fluidcontrol device 900 includes a housing 930 and an actuator 950, which canbe arranged, for example, in a modular configuration or the like. Theactuator 950 includes an inlet 952 configured to be placed in fluidcommunication with a bodily fluid source and an outlet 953 configured tobe coupled to a fluid collection device 980. In the embodiment shown inFIG. 26 , the fluid collection device 980 is a transfer adapterconfigured to be coupled to one or more reservoirs such as, for example,an evacuated container, a sample bottle, a culture bottle, etc. In suchembodiments, the reservoir can be sealed prior to being coupled to thetransfer adapter (i.e., the fluid collection device 980) and oncecoupled the seal can be punctured, displaced, deformed, and/or otherwiseunsealed to expose the outlet 953 to the negative pressure within thereservoir. Thus, the fluid control device 900 can function in asubstantially similar manner to the control device 800 described abovewith reference to FIGS. 19-25 .

While the fluid control device 800 is shown as including the actuatorrod 862 that includes the first end portion 863 and the second portion864 on which a force can be exerted to transition the device 800 betweenits first and second configurations, states, and/or positions, in otherembodiments, a control device can include an actuator having anysuitable configuration. For example, the fluid control device 900includes an actuator rod 962 having only a single end portion thatextends beyond the body 951 of the actuator 950, as shown in FIG. 26 .In such embodiments, the device 900 can be used to fill a fluidcollection device such as, for example, a sample reservoir, container,bottle, etc. and if it is desirable for more than one sample to becollected, the user can, for example, decouple the inlet 952 from alumen-containing device and/or any suitable device otherwise placing theinlet 952 in fluid communication with the bodily fluid source. Oncedecoupled, the user can couple the inlet of a new control device 900 tothe lumen-containing device and/or the like and can collect one or moreadditional samples in a manner similar to that described above withreference to the control device 800.

As described above, some fluid control device described herein can beand/or can have a modular configuration in which one or more componentscan be coupled to collectively form a fluid control device having adesired set of characteristics or the like. For example, the fluidcontrol device 800 shown in FIGS. 19-25 includes the housing 830 and theactuator 850 in one modular arrangement. It should be understood,however, that a control device can have any suitable modulararrangement. For example, FIG. 27 illustrates a modular fluid controldevice 1000 according to an embodiment. The fluid control device (alsoreferred to herein as “device”) includes a housing 1030 forming and/ordefining a sequestration chamber 1034, and an actuator 1050 formingand/or having an inlet 1052 and an outlet 1053. The device 1000 can besubstantially similar to the control device 800 described in detailabove but can be arranged such that housing 1030 is disposed indifferent position and/or orientation relative to the actuator 1050. Insome embodiments, varying the arrangement may, for example, enhanceusability, visibility, and/or the like and/or may otherwise allow for amore compact design.

As another example, FIG. 28 illustrates a modular fluid control device1100 according to an embodiment. The fluid control device (also referredto herein as “device”) includes a housing 1130 forming and/or defining asequestration chamber 1134, and an actuator 1150 forming and/or havingan inlet 1152 and an outlet 1153. The device 1100 can be substantiallysimilar to the control device 800 described in detail above but can bearranged such that housing 1130 is disposed in different position and/ororientation relative to the actuator 1150. Moreover, as shown in FIG. 28, the actuator 1150 can be arranged such that the inlet 1152 and theoutlet 1153 are disposed in substantially perpendicular positionsrelative to one another. As described above, in some embodiments,varying the arrangement may, for example, enhance usability, visibility,and/or the like and/or may otherwise allow for a more compact design.While examples of modular fluid control devices are shown herein, itshould be understood that such embodiments are presented by way ofexample and not limitation. Thus, while specific arrangements and/ororientations may be described herein, the devices and/or conceptsdescribed herein are not intended to be limited to those shown herein.

While the housings 230, 330, 830, 930, 1030, and 1130 have been shownand described herein as including and/or defining a sequestrationchamber that is arranged in a serpentine-like configuration, in otherembodiments, a housing and/or any other suitable portion of a controldevice can include and/or can define a sequestration chamber having anysuitable configuration. For example, FIGS. 29-34 illustrate a fluidcontrol device 1200 according to an embodiment. The fluid control device1200 can be similar in at least form and/or function to the fluidcontrol devices described herein. More specifically, portions of thefluid control device 1200 can be similar to and/or substantially thesame as corresponding portions of the fluid control devices 200, 300,800, 900, 1000, and/or 1100 described above. Accordingly, such portionsof the fluid control device 1200 are not described in further detailherein.

The fluid control device 1200 (also referred to herein as “controldevice” or “device”) includes a housing 1230 and an actuator 1250. Asdescribed above with reference to the control device 800, the controldevice 1200 can be arranged in a modular configuration such that thehousing 1230 and the actuator 1250 can be physically and fluidicallycoupled to form the control device 1200. In other embodiments, thecontrol device 1200 need not be modular. That is to say, in someembodiments, the control device 1200 can be assembled duringmanufacturing and delivered to a supplier and/or end user as anassembled device. In other embodiments, the control device can bemonolithically formed and/or coupled to a fluid collection device in anysuitable manner, as described in detail above.

The housing 1230 of the control device 1200 can be any suitable shape,size, and/or configuration. For example, in some embodiments, thehousing 1230 can be substantially similar in at least form and/orfunction to the housing 830 described in detail above. Accordingly, suchsimilar portions of the housing 1230 are identified below but may not bedescribed in further detail herein.

As shown in FIGS. 29-31 , the housing 1230 forms and/or defines asequestration chamber 1234 that is in selective fluid communication witha first port 1245 and a second port 1246. The second port 1246 isconfigured to receive, include, and/or define a flow controller 1242(see e.g., FIG. 30 ) and a restricted flow path 1232 (see e.g., FIG. 31). Although shown as including the restricted flow path 1232, in otherembodiments, a housing need not include or receive a restricted flowpath (e.g., when excessive negative pressure being applied to thesequestration chamber 1234 is unlikely or otherwise not intended such aswhen a fluid collection device is a syringe or the like). The first port1245 and the second port 1246 are configured to be at least fluidicallycoupled to a portion of the actuator 1250 to allow for selective fluidflow between the housing 1230 and the actuator 1250. As described infurther detail herein, the sequestration chamber 1234 is configured (1)to receive a selective flow and/or volume of bodily fluid from a portionof the actuator 1250 via the first port 1245, and (2) to sequester(e.g., separate, segregate, contain, retain, isolate, etc.) the flowand/or volume of bodily fluid (e.g., an initial or first flow and/orvolume of bodily fluid or any portion thereof) within the sequestrationchamber 1234.

The sequestration chamber 1234 can have any suitable shape, size, and/orconfiguration. For example, in some embodiments, the sequestrationchamber 1234 can have any suitable size, volume, and/or fluid capacitysuch as, for example, those described above with reference to thesequestration chamber 134. In the embodiment shown in FIGS. 29-34 , thesequestration chamber 1234 can be, for example, a fluid flow path thatextends through and/or that is defined by at least a portion of thehousing 1230. In some embodiments, the sequestration chamber 1234 can besubstantially similar in at least form and/or function to thesequestration chamber 834 described above with reference to FIGS. 19-25. The sequestration chamber 1234 and/or the housing 1230 can differ fromthe sequestration chamber 834 and/or the housing 830 by being arrangedin a spiral configuration with the first port 1245 being in fluidcommunication with, for example, an inner portion of the spiraledsequestration chamber 1234 and the second port 1246 being in fluidcommunication with, for example, an outer portion of the spiraledsequestration chamber, as shown in FIG. 30 . In some embodiments, thesequestration chamber 1234 can be, for example, a channel or the likeformed in a portion of the housing 1230.

In some embodiments, the channel forming at least a portion of thesequestration chamber 1234 can have a relatively small cross-sectionalshape and/or size that can reduce and/or substantially prevent a mixingof an initial volume of bodily fluid drawn into the sequestrationchamber 1234 (channel) and a volume of air within the sequestrationchamber 1234 (e.g., a volume of air that has not been vented or purged,as described in further detail herein). For example, in some instances,the relatively small cross-sectional shape and/or size of thesequestration chamber 1234 (channel), a surface tension associated withthe bodily fluid flowing into the sequestration chamber 1234, and acontact angle between a surface of the housing 1230 forming thesequestration chamber 1234 and the bodily fluid flowing into thesequestration chamber 1234 can collectively limit and/or substantiallyprevent a mixing of the bodily fluid and a volume of air within thesequestration chamber 1234.

As shown in FIG. 30 , the housing 1230 can include and/or can be coupledto a cover 1238 configured to enclose the channel, thereby forming thesequestration chamber 1234. The cover 1238 can be coupled to the housing1230 in any suitable manner (e.g., via a friction fit, snap fit,interference fit, an adhesive, one or more mechanical fasteners, laserwelding, ultrasonic welding, plasma techniques, annealing, heat bodingand/or any other suitable coupling means or combination thereof). Inother embodiments, the cover 1238 is monolithically formed with and/orcoupled to the housing 1230. Moreover, in some embodiments, the cover1238 can be at least partially transparent to allow a user to visualizea flow of bodily fluid through the sequestration chamber 1234. In someembodiments, the arrangement of the housing 1230 and the cover 1238 can,for example, facilitate one or more manufacturing processes and/or canfacilitate use of the control device 1200.

As shown in FIG. 30 , the housing 1230 includes and/or defines a flowcontroller 1242 and a restricted flow path 1232. The flow controller1242 can be, for example, a valve, membrane, diaphragm, restrictor,vent, a selectively permeable member, port, etc. configured toselectively control (at least in part) a flow of fluids into and/or outof the sequestration chamber 1234 and/or any other suitable portion ofthe housing 1230. For example, the flow controller 1242 can be aselectively permeable fluid barrier (e.g., a blood barrier) thatincludes and/or is formed of a porous material configured to selectivelyallow a flow of gas therethrough but to prevent a flow of a liquidtherethrough. As such, the flow controller 1242 can be configured tovent and/or purge a volume of air within the sequestration chamber 1234through the flow controller 1242 in response to a negative pressuredifferential within a portion of the control device 1200. Such a ventingand/or purging of the volume of air within the sequestration chamber1234 can result in a suction force and/or negative pressure differentialbeing exerted and/or applied in or on the sequestration chamber 1234that is operable to draw in the initial volume of bodily fluid.Moreover, the use of a selectively permeable fluid barrier can allow forthe venting and/or purging of air without allowing a volume of bodilyfluid to pass through the flow controller 1242. Accordingly, in someembodiments, the flow controller 1242 can be substantially similar tothe flow controller 242 described in detail above with reference toFIGS. 2-5 and thus, is not described in further detail herein.

The actuator 1250 of the control device 1200 can be any suitable shape,size, and/or configuration. For example, in some embodiments, theactuator 1250 can be substantially similar in at least form and/orfunction to the actuator 850 described in detail above. Accordingly,such similar portions of the actuator 1250 are identified below but maynot be described in further detail herein.

As shown in FIGS. 32-34 , the actuator 1250 includes a body 1251 and anactuator rod 1262. The body 1251 of the actuator 1250 includes an inlet1252 and an outlet 1253. The inlet 1252 and the outlet 1253 can besubstantially similar in at least form and/or function to the inlet 852and the outlet 853, respectively, described above with reference toFIGS. 19-25 . Thus, the inlet 1252 is configured to be placed in fluidcommunication with a bodily fluid source to receive a flow of bodilyfluid therefrom (e.g., via a lumen-containing device such as a needle,IV catheter, PICC line, or the like). The outlet 1253 is configured tobe fluidically coupled to a fluid collection device (not shown in FIGS.29-34 ) such as, for example, a sample reservoir, a syringe, and/orother intermediary bodily fluid transfer device, adapter, or vessel suchas, for example, a transfer device similar to those described in the'510 publication. In some embodiments, such a transfer device canprovide a negative pressure and/or can act as an external energy sourceto enable desired functionality and fluid flow pathdynamics/characteristics of the control device 1200.

The body 1251 of the actuator 1250 includes and/or defines a first port1258 and a second port 1259. The first port 1258 is in fluidcommunication with the inlet 1252 and the second port 1259 is in fluidcommunication with the outlet 1252. In addition, the first port 1258 andthe second port 1259 are configured to be at least fluidically coupledto the first port 1245 and the second port 1246, respectively, of thehousing 1230. In some embodiments, the arrangement of the ports 1258 and1259 of the actuator 1250 and the ports 1245 and 1246 of the housing1230 can allow for and/or otherwise can provide a means of physicallycoupling the housing 1230 to the actuator 1250 as well as fluidicallycoupling the housing 1230 to the actuator 1250. That is to say, in someembodiments, the arrangement of the ports 1258 and 1259 of the actuator1250 and the ports 1245 and 1246 of the housing 1230 can allow for amodular configuration or arrangement as described above with referenceto the control device 800. In other embodiments, the housing 1230 and/oractuator 1250 need not be modular.

In some embodiments, the body 1251 and the actuator rod 1262collectively include and/or collectively form a lock configured to atleast temporarily lock the actuator 1250. For example, in someembodiments, the body 1251 and the actuator rod 1262 can each define anopening 1257 in or through which a locking member can be disposed. Insuch embodiments, when the locking member (not shown in FIG. 32 ) isdisposed in the openings 1257, the locking member can limit and/orsubstantially prevent the actuator rod 1262 from being moved relative tothe body 1251. On the other hand, removing the locking member from theopenings 1257 can allow the actuator rod 1262 to be moved relative tothe body 1251. While described as forming a lock, in some embodiments,the body 1251 and the actuator rod 1262 collectively include and/orcollectively form a feature and/or arrangement that can limit and/orsubstantially prevent the actuator rod 1262 from being pulled out of thebody 1251. In such embodiments, the feature can be a snap, a lock, acatch, and/or any other suitable feature and/or arrangement.

As shown in FIGS. 33 and 34 , a portion of the actuator rod 1262includes and/or is coupled to a set of seals 1265. The seals 1265 canbe, for example, o-rings, over-molded elastomeric material, raisedprotrusions, and/or the like. The arrangement of the actuator 1262 andthe body 1251 of the actuator 1250 can be such that the seals 1265 formone or more fluid tight seals between the actuator rod 1262 and theinner surface of the body 1251, as described above with reference to theactuator 850. In the embodiment shown in FIGS. 33 and 34 , the actuatorrod 1262 includes and/or is coupled to three seals 1265 which formand/or define a first fluid flow path 1233 within the body 1251 of theactuator 1250 and a second fluid flow path 1254 within the body 1251 ofthe actuator 1250. In other embodiments, any number of seals may be usedto achieve desired performance.

As described above with reference to the device 800, the device 1200 canbe used to procure a bodily fluid sample having reduced contaminationfrom microbes such as, for example, dermally residing microbes, microbesexternal to the bodily fluid source, and/or the like. For example, theactuator rod 1262 is configured to be moved or transitioned relative tothe body 1251 between a first position or configuration and a secondposition or configuration. In some embodiments, the transition of theactuator rod 1262 can be achieved by and/or can otherwise result fromuser interaction and manipulation of the actuator rod 1262,automatically in response to negative pressure and associated flowdynamics within the device 1200, and/or enacted by or in response to anexternal energy source which creates dynamics that result in thetransitioning of the actuator rod 1262. As shown in FIG. 33 , when inthe first position and/or configuration, the inlet 1252 of the actuator1250 is in fluid communication with the first fluid flow path 1233,which in turn, is in fluid communication with the first port 1258. Theoutlet 1253 of the actuator 1250 is in fluid communication with thesecond fluid flow path 1254, which in turn, is in fluid communicationwith the second port 1259. Thus, when in the actuator 1250 and/oractuator rod 1262 is in the first position and/or configuration (e.g.,when the control device 1200 is in a first state or operating mode), thenegative pressure within the fluid collection device (not shown in FIGS.29-34 ) can result in a negative pressure (or negative pressuredifferential) within at least a portion of the sequestration chamber1234 that is operable in drawing at least a portion of an initial flow,amount, or volume of bodily fluid from the inlet 1252, through the firstfluid flow path 1233, and into the sequestration chamber 1234. Moreover,in some instances, the initial volume and/or flow of bodily fluid can betransferred into the sequestration chamber 1234 until, for example, thebodily fluid disposed within the sequestration chamber 1234 transitionsthe flow controller 1242 from an open or unsealed configuration or state(e.g., one in which a flow of gas or air can be drawn therethrough) to asealed configuration or state (e.g., one in which a flow of gas andliquid cannot be drawn therethrough).

In some instances, a force can be exerted on the end portion 1263 of theactuator rod 1262 to place the actuator rod 1262 and/or actuator 1250 inits second position and/or configuration, as shown in FIG. 34 . Asdescribed above, in some instances, prior to exerting the force on theend portion 1263 of the actuator rod 1262, the actuator 1250 may betransitioned from a locked configuration or state to an unlockedconfiguration or state. When the actuator rod 1262 and/or the actuator1250 is placed in its second position and/or configuration (e.g., whenthe control device 1200 is transitioned to a second state or operatingmode), the inlet 1252 and the outlet 1253 of the actuator 1250 are eachin fluid communication with the second fluid flow path 1254 while thefirst fluid flow path 1233 is sequestered, isolated, and/or otherwisenot in fluid communication with the inlet 1252 and the outlet 1253. Asdescribed in detail above, in some instances, contaminants such as, forexample, dermally residing microbes or the like dislodged during thevenipuncture event or throughout the bodily fluid collection process,can be entrained and/or included in the initial volume of the bodilyfluid and thus, are sequestered in the sequestration chamber 1234 whenthe initial volume is sequestered therein. As such, the negativepressure otherwise exerted on or through the sequestration chamber 1234is now exerted on or through the second fluid flow path 1254. Inresponse, bodily fluid can flow from the inlet 1252, through the secondfluid flow path 1254, through the outlet 1253, and into the fluidcollection device coupled to the outlet 1253. Accordingly, the device1200 can function in a manner substantially similar to that of thedevice 800 and thus, the function of the device 1200 is not described infurther detail herein.

FIGS. 35-40 illustrate a fluid control device 1300 according to anembodiment. The fluid control device 1300 can be similar in at leastform and/or function to the fluid control devices described herein. Morespecifically, portions of the fluid control device 1300 can be similarto and/or substantially the same as corresponding portions of the fluidcontrol devices 200, 300, 800, 900, 1000, 1100, and/or 1200 describedabove. Accordingly, such portions of the fluid control device 1300 arenot described in further detail herein.

The fluid control device 1300 (also referred to herein as “controldevice” or “device”) includes a housing 1330 and an actuator 1350. Asdescribed above with reference to the control devices 800, the controldevice 1300 can be arranged in a modular configuration such that thehousing 1330 and the actuator 1350 can be physically and fluidicallycoupled to form the control device 1300. In other embodiments, thecontrol device 1300 need not be modular. That is to say, in someembodiments, the control device 1300 can be assembled duringmanufacturing and delivered to a supplier and/or end user as anassembled device. In other embodiments, the device 1300 can bemonolithically formed and/or collectively formed with, for example, afluid collection device, as described above.

The housing 1330 of the control device 1300 can be any suitable shape,size, and/or configuration. As shown in FIGS. 35-37 , the housing 1330forms and/or defines a sequestration chamber 1334 that is in selectivefluid communication with a first port 1345 and a second port 1346. Thesecond port 1346 is configured to receive, include, and/or define a flowcontroller 1342 (see e.g., FIG. 36 ) and a restricted flow path 1332(see e.g., FIG. 37 ). The first port 1345 and the second port 1346 areconfigured to be at least fluidically coupled to a portion of theactuator 1350 to allow for selective fluid flow between the housing 1330and the actuator 1350. As described in further detail herein, thesequestration chamber 1334 is configured (1) to receive a selective flowand/or volume of bodily fluid from a portion of the actuator 1350 viathe first port 1345, and (2) to sequester (e.g., separate, segregate,contain, retain, isolate, etc.) the flow and/or volume of bodily fluid(e.g., at least a portion of an initial or first flow and/or volume ofbodily fluid) within the sequestration chamber 1334. The sequestrationchamber 1334 can have any suitable shape, size, and/or configuration.For example, in some embodiments, the sequestration chamber 1334 can be,for example, a channel or the like formed in a portion of the housing1330 and the housing 1330 can include and/or can be coupled to a cover1338 configured to enclose the channel, thereby forming thesequestration chamber 1334. In some embodiments, the housing 1330 can besubstantially similar in at least form and/or function to the housing1230 described in detail above with reference to FIGS. 29-34 .Accordingly, the housing 1330 is not described in further detail herein.

The actuator 1350 of the control device 1300 can be any suitable shape,size, and/or configuration. For example, in some embodiments, theactuator 1350 can be substantially similar in at least form and/orfunction to the actuators 850 and/or 1250 described in detail above.Accordingly, such similar portions of the actuator 1350 are identifiedbelow but may not be described in further detail herein.

As shown in FIGS. 38-40 , the actuator 1350 includes a body 1351 and anactuator rod 1362. The body 1351 of the actuator 1350 includes an inlet1352 and an outlet 1353. The inlet 1352 and the outlet 1353 can besubstantially similar in at least form and/or function to the inlet 852and the outlet 853, respectively, described above with reference toFIGS. 19-25 . Thus, the inlet 1352 is configured to be placed in fluidcommunication with a bodily fluid source to receive a flow of bodilyfluid therefrom (e.g., via a lumen-containing device such as a needle,IV catheter, surgical tubing, other standard bodily-fluid transferdevice, PICC line, or the like). The outlet 1353 is configured to befluidically coupled to a fluid collection device (not shown in FIGS.35-40 ) such as, for example, a sample reservoir, a syringe, and/orother intermediary bodily fluid transfer device, adapter, or vessel suchas, for example, a transfer device similar to those described in the'510 publication.

The body 1351 of the actuator 1350 includes and/or defines a first port1358 and a second port 1359. The first port 1358 is in fluidcommunication with the inlet 1352 and the second port 1359 is in fluidcommunication with the outlet 1353. In addition, the first port 1358 andthe second port 1359 are configured to be at least fluidically coupledto the first port 1345 and the second port 1346, respectively, of thehousing 1330. In some embodiments, the arrangement of the ports 1358 and1359 of the actuator 1350 and the ports 1345 and 1346 of the housing1330 can allow for and/or otherwise can provide a means of physicallycoupling the housing 1330 to the actuator 1350 as well as fluidicallycoupling the housing 1330 to the actuator 1350. That is to say, in someembodiments, the arrangement of the ports 1358 and 1359 of the actuator1350 and the ports 1345 and 1346 of the housing 1330 can allow for amodular configuration or arrangement as described above with referenceto the control device 800. In other embodiments, the housing 1330 and/oractuator 1350 need not be modular.

As shown in FIGS. 39 and 40 , a portion of the actuator rod 1362includes and/or is coupled to a set of seals 1365. The seals 1365 canbe, for example, o-rings, elastomeric material, silicone or any othersuitable material or configuration as described above with reference tothe seals 1265. The arrangement of the actuator 1362 and the body 1351of the actuator 1350 can be such that the seals 1365 form one or morefluid tight seals between the actuator rod 1362 and the inner surface ofthe body 1351, as described above with reference to the actuator 850. Inthe embodiment shown in FIGS. 33 and 34 , the actuator rod 1362 includesand/or is coupled to three seals 1365 which form and/or define a firstfluid flow path 1333 within the body 1351 of the actuator 1350 and asecond fluid flow path 1354 within the body 1351 of the actuator 1350.

As described above with reference to the device 800, the device 1300 canbe used to procure a bodily fluid sample having reduced contaminationfrom microbes such as, for example, dermally residing microbes, microbesexternal to the bodily fluid source, and/or the like. For example, theactuator rod 1362 is configured to be moved or transitioned relative tothe body 1351 between a first position or configuration and a secondposition or configuration. As shown in FIG. 39 , when in the firstposition and/or configuration, the inlet 1352 of the actuator 1350 is influid communication with the first fluid flow path 1333, which in turn,is in fluid communication with the first port 1358. The outlet 1353 ofthe actuator 1350 is in fluid communication with the second fluid flowpath 1354, which in turn, is in fluid communication with the second port1359. Thus, when in the actuator 1350 and/or actuator rod 1362 is in thefirst position and/or configuration (e.g., when the control device 1300is in a first state or operating mode), the negative pressure within thefluid collection device (not shown in FIGS. 35-40 ) can result in anegative pressure (or negative pressure differential) within at least aportion of the sequestration chamber 1334 that is operable in drawing atleast a portion of an initial flow, amount, or volume of bodily fluidfrom the inlet 1352, through the first fluid flow path 1333, and intothe sequestration chamber 1334. Moreover, in some instances, the initialvolume and/or flow of bodily fluid can be transferred into thesequestration chamber 1334 until, for example, the bodily fluid disposedwithin the sequestration chamber 1334 transitions the flow controller1342 from an open or unsealed configuration or state (e.g., one in whicha flow of gas or air can be drawn therethrough) to a sealedconfiguration or state (e.g., one in which a flow of gas and liquidcannot be drawn therethrough).

In some instances, a force can be exerted on a first end portion 1363 ofthe actuator rod 1362 to place the actuator rod 1362 and/or actuator1350 in its second position, state, operating mode, and/orconfiguration, as shown in FIG. 35 . As described above, in someinstances, prior to exerting the force on the first end portion 1363 ofthe actuator rod 1362, the actuator 1350 may be transitioned from alocked configuration or state to an unlocked configuration or state. Insome embodiments, the transition of the actuator rod 1362 can beachieved by and/or can otherwise result from user interaction andmanipulation of the actuator rod 1362, automatically in response tonegative pressure and associated flow dynamics within the device 1300,and/or enacted by or in response to an external energy source whichcreates dynamics that result in the transitioning of the actuator rod1362.

When the actuator rod 1362 and/or the actuator 1350 is placed in itssecond position and/or configuration (e.g., when the control device 1300is transitioned to a second state or operating mode), the inlet 1352 andthe outlet 1353 of the actuator 1350 are each in fluid communicationwith the second fluid flow path 1354 while the first fluid flow path1333 is sequestered, isolated, and/or otherwise not in fluidcommunication with the inlet 1352 and the outlet 1353. As described indetail above, in some instances, contaminants such as, for example,dermally residing microbes or the like dislodged during the venipunctureevent or throughout the bodily-fluid collection process, can beentrained and/or included in the initial volume of the bodily fluid andthus, are sequestered in the sequestration chamber 1334 when the initialvolume is sequestered therein. As such, the negative pressure otherwiseexerted on or through the sequestration chamber 1334 is now exerted onor through the second fluid flow path 1354. In response, bodily fluidcan flow from the inlet 1352, through the second fluid flow path 1354,through the outlet 1353, and into the fluid collection device coupled tothe outlet 1353. Accordingly, the device 1300 can function in a mannersubstantially similar to that of the device 800 and thus, the functionof the device 1300 is not described in further detail herein.

In some instances, it may be desirable to isolate the negative pressuresource (e.g., the fluid collection device from the inlet 1353 such as,for example, if it is desirable to collect multiple samples of bodilyfluid using multiple fluid collection devices (e.g., syringes or thelike). For example, in some instances, after filling the fluidcollection device the user can engage the actuator 1350 and exert aforce on a second end portion 1364 of the actuator rod 1362 to moveand/or transition the actuator rod 1362 from its second position and/orconfiguration toward its first position and/or configuration. As such,the second fluid flow path 1354 no longer places the inlet 1352 in fluidcommunication with the outlet 1353. Moreover, the flow controller 1342can remain in the sealed state or configuration (e.g., fully saturated,wetted, and/or otherwise preventing flow therethrough) such that theoutlet 1353 is substantially sequestered or isolated from the rest ofthe control device 1300. In some instances, the user can then remove thefilled fluid collection device and can couple a new fluid collectiondevice to the outlet 1353. With the new fluid collection device coupledto the outlet 1353, the user can, for example, exert a force on thefirst end portion 1363 of the actuator rod 1362 to move and/ortransition the actuator rod 1362 back to its second position, state,and/or configuration, as described above with reference to the actuator850.

FIGS. 41-44 illustrate a fluid control device 1400 according to anembodiment. The fluid control device 1400 can be similar in at leastform and/or function to the fluid control devices described herein. Morespecifically, portions of the fluid control device 1400 can be similarto and/or substantially the same as corresponding portions of the fluidcontrol devices 200, 300, 800, 900, 1000, 1100, 1200, and/or 1300described above. Accordingly, such portions of the fluid control device1400 are not described in further detail herein.

The fluid control device 1400 (also referred to herein as “controldevice” or “device”) includes a housing 1430 and an actuator 1450. Asdescribed above with reference to the control device 800, the controldevice 1400 can be arranged in a modular configuration such that thehousing 1430 and the actuator 1450 can be physically and fluidicallycoupled to form the control device 1400. In other embodiments, thecontrol device 1400 need not be modular. That is to say, in someembodiments, the control device 1400 can be assembled duringmanufacturing and delivered to a supplier and/or end user as anassembled device. In other embodiments, the device 1400 can bemonolithically formed and/or collectively formed with, for example, afluid collection device, as described above.

The housing 1430 of the control device 1400 can be any suitable shape,size, and/or configuration. The housing 1430 is configured to be inselective fluid communication with a portion of the actuator 1450 via afirst port 1458 and a second port 1459. As shown in FIGS. 43 and 44 ,the housing 1430 includes a bladder 1478 that can be transitioned from afirst configuration and/or state to a second configuration and/or stateto form and/or define a sequestration chamber 1434. As described infurther detail herein, the bladder 1478 is configured to transition fromthe first configuration and/or state (FIG. 43 ) to the secondconfiguration and/or state (FIG. 44 ) to form and/or define thesequestration chamber 1434, which in turn, is configured to receive aselective flow and/or volume of bodily fluid from a portion of theactuator 1450 via the first port 1458. After the bladder 1478 is placedin the second configuration and/or state, the sequestration chamber 1434can sequester (e.g., separate, segregate, contain, retain, isolate,etc.) the flow and/or volume of bodily fluid (e.g., at least a portionof an initial or first flow and/or volume of bodily fluid) within thesequestration chamber 1434.

While the bladder 1478 is particularly shown in FIGS. 43 and 44 , inother embodiments, the bladder 1478 can be any suitable shape, size,and/or configuration. Similarly, the bladder 1478 can be formed of anysuitable material (e.g., any suitable biocompatible material such asthose described herein and/or any other suitable material). In someembodiments, the bladder 1478 can be arranged and/or configured as, forexample, a bellows, an expandable bag, a flexible pouch, and/or anyother suitable reconfigurable container or the like. In addition, thesequestration chamber 1434 formed by the bladder 1478 can have anysuitable shape, size, and/or configuration. In some embodiments, thehousing 1430 can be substantially similar in at least form and/orfunction to the housing 1230 and/or 1330 described in detail above withreference to FIGS. 29-34 and FIGS. 35-40 , respectively. Accordingly,the housing 1430 is not described in further detail herein.

The actuator 1450 of the control device 1400 can be any suitable shape,size, and/or configuration. For example, in some embodiments, theactuator 1450 can be substantially similar in at least form and/orfunction to the actuators 850, 1250, and/or 1350 described in detailabove. Accordingly, such similar portions of the actuator 1450 areidentified below but may not be described in further detail herein.

As shown in FIGS. 41-44 , the actuator 1450 includes a body 1451 and anactuator rod 1462. The body 1451 of the actuator 1450 includes an inlet1452 and an outlet 1453. The inlet 1452 and the outlet 1453 can besubstantially similar in at least form and/or function to the inlet 1252and the outlet 1253, respectively, described above with reference toFIGS. 29-34 . Thus, the inlet 1452 is configured to be placed in fluidcommunication with a bodily fluid source to receive a flow of bodilyfluid therefrom (e.g., via a lumen-containing device such as a needle,IV catheter, surgical tubing, other standard bodily-fluid transferdevice, PICC line, or the like). The outlet 1453 is configured to befluidically coupled to a fluid collection device (not shown in FIGS.41-44 ) such as, for example, a sample reservoir, a syringe, and/orother intermediary bodily fluid transfer device, adapter, or vessel suchas, for example, a transfer device similar to those described in the'510 publication.

The body 1451 of the actuator 1450 includes and/or defines the firstport 1458 and the second port 1459. Although not shown, the first port1458 is configured to be in fluid communication with the inlet 1452 andthe second port 1459 is configured to be in fluid communication with theoutlet 1453. In addition, the first port 1458 is configured to be influid communication with the housing 1430 and more particularly, aninner volume or an inlet side of the bladder 1478 that forms thesequestration chamber 1434. The second port 1459 is configured to be influid communication with a portion of the housing 1430 defined betweenan inner surface of the housing 1430 and an outer surface of the bladder1478. In other words, the second port 1459 is in fluid communicationwith a portion of the housing 1430 that is isolated and/or sequesteredfrom the inner volume of the bladder 1478 that forms the sequestrationchamber 1434. In some embodiments, the arrangement of the ports 1458 and1459 of the actuator 1450 can allow for and/or otherwise can provide ameans of physically coupling the housing 1430 to the actuator 1450 aswell as fluidically coupling the housing 1430 to the actuator 1450. Thatis to say, in some embodiments, the arrangement of the ports 1458 and1459 of the actuator 1450 can allow for a modular configuration orarrangement as described above with reference to the control device 800.In other embodiments, the housing 1430 and/or actuator 1450 need not bemodular.

Although not shown in FIGS. 41-44 , a portion of the actuator rod 1462includes and/or is coupled to a set of seals. The seals can be, forexample, o-rings, elastomeric material, silicone or any other suitablematerial or configuration as described above with reference to the seals1265 and/or 1365. The arrangement of the actuator rod 1462 and the body1451 of the actuator 1450 can be such that the seals form one or morefluid tight seals between the actuator rod 1462 and the inner surface ofthe body 1451, as described above with reference to the actuators 850,1250, and/or 1350. Moreover, as described above with reference to theactuators 1250 and/or 1350, the actuator rod 1462 can include and/or canbe coupled to a set seals which selectively form and/or define a firstfluid flow path configured to place the inlet 1452 of the actuator 1450in fluid communication with the first port 1458 (e.g., when in a firstposition, state, operating mode, and/or configuration) and a secondfluid flow path configured to place the inlet 1452 in fluidcommunication with the outlet 1453 (e.g., when in a second position,state, operating mode, and/or configuration).

As described above with reference to the devices 800, 1200, and/or 1300,the device 1400 can be used to procure a bodily fluid sample havingreduced contamination from microbes such as, for example, dermallyresiding microbes, microbes external to the bodily fluid source, and/orthe like. For example, as described above with reference to the devices1200 and/or 1300, the actuator rod 1462 can be configured to be moved ortransitioned relative to the body 1451 between a first position orconfiguration and a second position or configuration. When in the firstposition and/or configuration, the inlet 1452 of the actuator 1450 is influid communication with, for example, the first fluid flow path, whichin turn, is in fluid communication with the first port 1458 (not shownin FIGS. 41-44 ). The outlet 1453 of the actuator 1450 is in fluidcommunication with the second fluid flow path 1454, which in turn, is influid communication with the second port 1459. Thus, when in theactuator 1450 and/or actuator rod 1462 is in the first position and/orconfiguration (e.g., when the control device 1400 is in a first state oroperating mode), the negative pressure within the fluid collectiondevice (not shown in FIGS. 41-44 ) can result in a negative pressure (ornegative pressure differential) within the portion of the housing 1430defined between the inner surface of the housing 1430 and the outersurface of the bladder 1478.

As shown in FIG. 43 , the bladder 1478 can be in a first state and/orconfiguration prior to the fluid collection device being coupled to theoutlet 1453. In some embodiments, for example, the bladder 1478 can havea flipped, inverted, collapsed, and/or empty configuration prior tocoupling the fluid collection device to the outlet 1453. As shown inFIG. 44 , the bladder 1478 can be configured to transition from thefirst state and/or configuration to a second state and/or configurationin response to the negative pressure differential resulting from thecoupling of the fluid collection device to the outlet 1453. In otherwords, the negative pressure differential can be operable to transitionthe bladder 1478 from a collapsed or unexpanded configuration and/orstate to an expanded configuration and/or state. For example, in someembodiments, the transitioning of the bladder 1478 can be similar to thetransitioning and/or “flipping” of the diaphragm 576, described abovewith reference to FIGS. 11 and 12 .

As described above, the bladder 1478 can be configured to transitionfrom the first configuration and/or state to the second configurationand/or state to form and/or define the sequestration chamber 1434. Insome embodiments, the transitioning of the bladder 1478 results in anincrease in an inner volume of the bladder 1478 (i.e., the sequestrationchamber 1434). The increase in the inner volume can, in turn, result ina negative pressure differential between the sequestration chamber 1434defined by the bladder 1478 and the inlet 1452 that is operable indrawing at least a portion of an initial flow, amount, or volume ofbodily fluid from the inlet 1452, through the first port 1458, and intothe sequestration chamber 1434. Moreover, in some instances, the initialvolume and/or flow of bodily fluid can be transferred into thesequestration chamber 1434 until, for example, the bladder 1478 is fullyexpanded, and/or until the negative pressure differential is reducedand/or equalized.

Having transferred the initial volume of bodily fluid into thesequestration chamber 1434, a force can be exerted on a first endportion 1463 of the actuator rod 1462 to place the actuator rod 1462and/or actuator 1450 in its second position, state, operating mode,and/or configuration, as described in detail above with reference to thedevices 1200 and/or 1300. As described above, in some instances, priorto exerting the force on the first end portion 1463 of the actuator rod1462, the actuator 1450 may be transitioned from a locked configurationor state to an unlocked configuration or state. In some embodiments, thetransition of the actuator rod 1462 can be achieved by and/or canotherwise result from user interaction and manipulation of the actuatorrod 1462, automatically in response to negative pressure and associatedflow dynamics within the device 1400, and/or enacted by or in responseto an external energy source which creates dynamics that result in thetransitioning of the actuator rod 1462.

When the actuator rod 1462 and/or the actuator 1450 is placed in itssecond position and/or configuration (e.g., when the control device 1400is transitioned to a second state or operating mode), the inlet 1452 andthe outlet 1453 of the actuator 1450 are placed in fluid communication(e.g., via the second fluid flow path (not shown)) while the first fluidflow path (not shown) and/or the first port 1458 is sequestered,isolated, and/or otherwise not in fluid communication with the inlet1452 and/or the outlet 1453. As described in detail above, in someinstances, contaminants such as, for example, dermally residing microbesor the like dislodged during the venipuncture event or throughout thebodily-fluid collection process, can be entrained and/or included in theinitial volume of the bodily fluid and thus, are sequestered in thesequestration chamber 1434 when the initial volume is sequesteredtherein. As such, the negative pressure otherwise exerted on or throughthe housing 1430 is now exerted on or through the outlet 1453 and theinlet 1452 via, for example, the second fluid flow path (not shown). Inresponse, bodily fluid can flow from the inlet 1452, through the body1451 of the actuator 1450, through the outlet 1453, and into the fluidcollection device coupled to the outlet 1453. Accordingly, the device1400 can function in a manner substantially similar to that of thedevices 800, 1200, and/or 1300 and thus, the function of the device 1400is not described in further detail herein.

While the device 1400 is described above as including the housing 1430and the actuator 1450, in other embodiments, a fluid control device canhave, for example, at least a partially integrated design. For example,FIGS. 45-50 illustrate a fluid control device 1500 according to anembodiment. The fluid control device 1500 can be similar in at leastform and/or function to the fluid control devices described herein. Morespecifically, portions of the fluid control device 1500 can be similarto and/or substantially the same as corresponding portions of at leastthe fluid control device 1400 described above with reference to FIGS.41-44 . Accordingly, such portions of the fluid control device 1500 arenot described in further detail herein.

The fluid control device 1500 (also referred to herein as “controldevice” or “device”) includes an actuator 1550 having an actuator body1551 and an actuator rod 1562. The actuator 1550 can be any suitableshape, size, and/or configuration. For example, in some embodiments, theactuator 1550 can be substantially similar in at least form and/orfunction to the actuators 850, 1250, 1350, and/or 1450 described indetail above. Accordingly, such similar portions of the actuator 1550are identified below but may not be described in further detail herein.

As shown in FIGS. 45-50 , the actuator 1550 includes an inlet 1552 andan outlet 1553, each of which is in fluid communication with the body1551. The inlet 1552 and the outlet 1553 can be substantially similar inat least form and/or function to the inlet 1252 and the outlet 1253,respectively, described above with reference to FIGS. 29-34 . Thus, theinlet 1552 is configured to be placed in fluid communication with abodily fluid source to receive a flow of bodily fluid therefrom (e.g.,via a lumen-containing device such as a needle, IV catheter, surgicaltubing, other standard bodily-fluid transfer device, PICC line, or thelike). The outlet 1553 is configured to be fluidically coupled to afluid collection device (not shown in FIGS. 45-50 ) such as, forexample, a sample reservoir, a syringe, and/or other intermediary bodilyfluid transfer device, adapter, or vessel such as, for example, atransfer device similar to those described in the '510 publication.

As shown in FIGS. 48-50 , the actuator 1550 includes a bladder 1578 thatcan be transitioned from a first configuration and/or state (FIG. 48 )to a second configuration and/or state (FIG. 49 ) to form and/or definea sequestration chamber 1534. As described in further detail herein, thebladder 1578 is configured to transition from the first configurationand/or state (FIG. 48 ) to the second configuration and/or state (FIGS.49 and 50 ) to form and/or define the sequestration chamber 1534, whichin turn, is configured to receive a selective flow and/or volume ofbodily fluid from the inlet 1552. After the bladder 1578 is placed inthe second configuration and/or state, the sequestration chamber 1534can sequester (e.g., separate, segregate, contain, retain, isolate,etc.) the flow and/or volume of bodily fluid (e.g., at least a portionof an initial or first flow and/or volume of bodily fluid) within thesequestration chamber 1534. As such, the bladder 1578 can besubstantially similar in at least form and/or function to the bladder1478 described above with reference to FIGS. 41-44 and thus, is notdescribed in further detail herein.

As shown in FIGS. 46 and 48-50 , the body 1551 of the actuator 1550includes and/or defines a port 1559 configured to be in fluidcommunication with the outlet 1553. In addition, the port 1559 defines afluid flow path that is configured to be in fluid communication with aportion of the actuator 1550 defined between an inner surface of thebody 1551 and an outer surface of the bladder 1578. In other words, theport 1559 is in fluid communication with a portion of the actuator 1550that is isolated and/or sequestered from the inner volume of the bladder1578 that forms and/or that is configured to form the sequestrationchamber 1534.

As described above with reference to the devices 1200, 1300, and/or1400, a portion of the actuator rod 1562 includes and/or is coupled to aset of seals 1565. The seals 1565 can be, for example, o-rings,elastomeric material, silicone or any other suitable material orconfiguration as described above with reference to the seals 1265 and/or1365. The arrangement of the actuator rod 1562 and the body 1551 of theactuator 1550 can be such that the seals 1565 form one or more fluidtight seals between the actuator rod 1562 and the inner surface of thebody 1551, as described above with reference to the actuators 850, 1250,and/or 1350. Moreover, as described above with reference to theactuators 1250 and/or 1350, the set seals 1565 can be arranged along theactuator rod 1562 to selectively form and/or define a fluid flow path1554 that is sequestered from and/or fluidically isolated from the inlet1552 when the actuator rod 1562 is in a first position and/orconfiguration and that is configured to place the inlet 1552 in fluidcommunication with the outlet 1553 when the actuator rod 1562 is in asecond position and/or configuration.

As described above with reference to the devices 800, 1200, 1300, and/or1400, the device 1500 can be used to procure a bodily fluid samplehaving reduced contamination from microbes such as, for example,dermally residing microbes, microbes external to the bodily fluidsource, and/or the like. For example, as described above with referenceto the devices 1200, 1300, and/or 1400, the actuator rod 1562 can beconfigured to be moved or transitioned relative to the body 1551 betweenthe first position or configuration and the second position orconfiguration. When in the first position and/or configuration, theinlet 1552 of the actuator 1550 is in fluid communication with a fluidflow path, which in turn, is in fluid communication with a portion ofthe body 1551 that is disposed on an inlet side of the bladder 1578. Inother words, the fluid flow path establishes fluid communication betweenthe inlet 1553 and the bladder 1578 and/or the sequestration chamber1534 at least partially defined by the bladder 1578 when the bladder1578 is transitioned to the second configuration and/or state. Theoutlet 1553 of the actuator 1550 is in fluid communication with the port1559. Thus, when in the actuator 1550 and/or actuator rod 1562 is in thefirst position and/or configuration (e.g., when the control device 1500is in a first state or operating mode), the negative pressure within thefluid collection device (not shown in FIGS. 45-50 ) can result in anegative pressure (or negative pressure differential) within the portionof the actuator body 1551 defined between the inner surface of the body1551 and the outer surface of the bladder 1578, as described above withreference to the device 1400.

As shown in FIG. 48 , the bladder 1578 can be in a first state and/orconfiguration prior to the fluid collection device being coupled to theoutlet 1553. In some embodiments, for example, the bladder 1578 can havea flipped, inverted, collapsed, and/or empty configuration prior tocoupling the fluid collection device to the outlet 1553. Moreover, whenthe actuator rod 1562 is in the first position and/or configuration, thefluid flow path 1554 is fluidically isolated from the inlet 1552.Accordingly, as shown in FIG. 49 , the bladder 1578 can be configured totransition from the first state and/or configuration to a second stateand/or configuration in response to the negative pressure differentialresulting from the coupling of the fluid collection device to the outlet1553. In other words, the negative pressure differential can be operableto transition the bladder 1578 from a collapsed or unexpandedconfiguration and/or state to an expanded configuration and/or state.For example, in some embodiments, the transitioning of the bladder 1578can be similar to the transitioning and/or “flipping” of the diaphragm576, described above with reference to FIGS. 11 and 12 . In otherembodiments, the bladder 1578 can be configured to transition between afirst state and/or configuration to a second state and/or configurationin any suitable manner such as any of those described herein.

As described above, the bladder 1578 can be configured to transitionfrom the first configuration and/or state to the second configurationand/or state to form and/or define the sequestration chamber 1534. Insome embodiments, the transitioning of the bladder 1578 results in anincrease in an inner volume of the bladder 1578 (i.e., the sequestrationchamber 1534). The increase in the inner volume can, in turn, result ina negative pressure differential between the sequestration chamber 1534defined by the bladder 1578 and the inlet 1552 that is operable indrawing at least a portion of an initial flow, amount, or volume ofbodily fluid from the inlet 1552 and a portion of the actuator body1551, and into the sequestration chamber 1534. Moreover, in someinstances, the initial volume and/or flow of bodily fluid can betransferred into the sequestration chamber 1534 until, for example, thebladder 1578 is fully expanded, and/or until the negative pressuredifferential is reduced and/or equalized.

Having transferred the initial volume of bodily fluid into thesequestration chamber 1534, a force can be exerted on a first endportion 1563 of the actuator rod 1562 to place the actuator rod 1562and/or actuator 1550 in its second position, state, operating mode,and/or configuration, as described in detail above with reference to thedevices 1200 and/or 1300. As described above, in some instances, priorto exerting the force on the first end portion 1563 of the actuator rod1562, the actuator 1550 may be transitioned from a locked configurationor state to an unlocked configuration or state. In some embodiments, thetransition of the actuator rod 1562 can be achieved by and/or canotherwise result from user interaction and manipulation of the actuatorrod 1562, automatically in response to negative pressure and associatedflow dynamics within the device 1500, and/or enacted by or in responseto an external energy source which creates dynamics that result in thetransitioning of the actuator rod 1562.

When the actuator rod 1562 and/or the actuator 1550 is placed in itssecond position and/or configuration (e.g., when the control device 1500is transitioned to a second state or operating mode), the inlet 1552 andthe outlet 1553 of the actuator 1550 are placed in fluid communicationvia the fluid flow path 1554 while the sequestration chamber 1534 issequestered, isolated, and/or otherwise not in fluid communication withthe inlet 1552 and/or the outlet 1553. As described in detail above, insome instances, contaminants such as, for example, dermally residingmicrobes or the like dislodged during the venipuncture event orthroughout the bodily-fluid collection process, can be entrained and/orincluded in the initial volume of the bodily fluid and thus, aresequestered in the sequestration chamber 1534 when the initial volume issequestered therein.

As described above with reference to the devices 1200 and/or 1300,transitioning the actuator rod 1562 to the second position and/orconfiguration is such that the fluid flow path 1554 places the inlet1552 in fluid communication with the outlet 1553. For example,transitioning the actuator rod 1562 to the second position and/orconfiguration can move the seals 1565 relative to the inlet 1552 suchthat the fluid flow path 1554 is placed in fluid communication with boththe inlet 1552 and the outlet 1553. As such, the negative pressureotherwise exerted on the outer surface of the bladder 1578 is nowexerted on or through the outlet 1553 and the inlet 1552 via the fluidflow path 1554. In response, bodily fluid can flow from the inlet 1552,through the fluid flow path 1554, through the outlet 1553, and into thefluid collection device coupled to the outlet 1553. Accordingly, thedevice 1500 can function in a manner substantially similar to that ofthe devices 800, 1200, 1300, and/or 1400 and thus, the function of thedevice 1500 is not described in further detail herein.

While the actuators 850, 1250, 1350, 1450, and 1550 have been describedin detail above as being transitioned in response to an external forcesuch as, for example, a force exerted by a user, in other embodiments, afluid control device can include one or more actuators that can betransitioned in response to any suitable force, input, change of stateor configuration, etc. For example, FIGS. 51 and 52 illustrate a portionof a fluid control device 1600 according to an embodiment. The fluidcontrol device 1600 can be similar in at least form and/or function tothe fluid control devices described herein. More specifically, portionsof the fluid control device 1600 can be similar to and/or substantiallythe same as corresponding portions of at least the fluid control devices500, 600, and/or 700 described above. Accordingly, such portions of thefluid control device 1600 are not described in further detail herein.

As shown in FIGS. 51 and 52 , the fluid control device 1600 (alsoreferred to herein as “control device” or “device”) includes a housing1630 having an inlet 1631 and an outlet 1636, and having and/or beingcoupled to an actuator 1650. As described in further detail herein, thehousing 1630 defines a set of fluid flow paths 1633 and 1654 configuredto establish fluid communication between one or more portions of thehousing 1630 to selectively receive a flow of fluid therethrough (e.g.,a liquid and/or a gas). The inlet 1631 is configured to be placed influid communication with a bodily fluid source to receive a flow ofbodily fluid therefrom (e.g., via a lumen-containing device such as aneedle or the like, as described in detail above). The outlet 1636 isconfigured to be fluidically coupled to a fluid collection device (notshown in FIGS. 51 and 52 ). The inlet 1631, the outlet 1636, and thefluid collection device can be substantially similar to those describedabove and thus, are not described in further detail herein.

The housing 1630 can be any suitable shape, size, and/or configuration.In some embodiments, the housing 1630 can have a size that is at leastpartially based on a volume of bodily fluid configured to be at leasttemporarily stored within one or more portions of the housing 1630. Asdescribed above, the housing 1630 of the control device 1600 isconfigured to (1) receive a flow and/or volume of bodily fluid via theinlet 1631 and (2) sequester (e.g., separate, segregate, contain,retain, isolate, etc.) the flow and/or volume of bodily fluid within asequestration chamber 1634 included in and/or at least partially formedby the housing 1630. In some embodiments, aspects of the housing 1630can be substantially similar, for example, to aspects of the housings630, 730, and/or 830. Accordingly, some portions and/or aspects of thehousing 1630 are not described in further detail herein.

The housing 1630 includes and/or is coupled to the actuator 1650configured to selectively control a flow of bodily fluid through thehousing 1630. In this embodiment, the actuator 1650 includes a diaphragm1676 and an actuator rod 1662 having a set of seals (e.g., seals 1665and 1666). As described in further detail herein, the diaphragm 1676 andthe actuator rod 1662 are configured to transition, move, and/orotherwise reconfigure within the housing 1630 in response to a negativepressure differential within at least a portion of the device. Morespecifically, the actuator 1650 is configured to move between a firststate in which the inlet 1631 is placed in fluid communication with thesequestration chamber 1634 and a second state in which the inlet 1631 isplaced in fluid communication with the outlet 1636 via the fluid flowpath 1654, as described in detail above with reference to the controldevice 500.

In some embodiments, the diaphragm 1676 can be similar to, for example,the diaphragms 576, 676, and/or 776 described in detail above.Accordingly, the diaphragm 1676 can be at least partially disposed in asequestration portion of the housing 1630 to define and/or to form atleast a portion of the sequestration chamber 1634. As described indetail above, the diaphragm 1676 can be configured to transition, move,flip, and/or otherwise reconfigure from a first state to a second statein response to a negative pressure differential, which can be operableto draw an initial volume of bodily fluid into the sequestration chamber1634 and/or to sequester the initial volume of bodily fluid in thesequestration chamber 1634 once disposed therein. Moreover, as shown inFIGS. 51 and 52 , the diaphragm 1676 can include and/or can be coupledto a flow controller 1642. The flow controller 1642 can be any suitableflow controller such as any of those described herein. For example, insome embodiments, the flow controller 1642 can be a semi-permeablemember or membrane such as an air permeable/liquid impermeable barrier(e.g., a blood barrier).

As described in detail above, the flow controller 1642 can be configuredto transition from a first state in which the flow controller 1642allows a flow of gas (e.g., air) to pass through the flow controller1642 while preventing a flow of liquid (e.g., bodily fluid) to passtherethrough, to a second state in which the flow controller 1642 limitsand/or substantially prevents a flow of gas and liquid to pass throughthe flow controller 1642. In some embodiments, the flow controller 1642can be configured to transition from the first state to the second statein response to contact with, for example, the initial volume of bodilyfluid (e.g., at least a portion of the initial volume of bodily fluidcan wet or saturate the flow controller 1642 to place the flowcontroller 1642 in the second state).

While the diaphragms 576, 676, and 776 are shown and described above asincluding a pin, rod, post, and/or the like that include and/or arecoupled to one or more seals (e.g., the seals 565, 665, and 765,respectively), in the embodiment shown in FIGS. 51 and 52 , thediaphragm 1676 includes a pin 1677 (e.g., a rod, an extension, aprotrusion, a latch, a lock, and/or any other suitable feature, member,and/or mechanism) that does not include and/or is not coupled to a seal.For example, in this embodiment, the pin 1677 extends through a portionof the housing 1630 to selectively engage a portion of the actuator rod1662, which in turn includes one or more seals (e.g., the seals 1665 and1666), as described in further detail herein.

As shown in FIGS. 51 and 52 , the actuator rod 1662 is movably disposedin, for example, an actuator portion 1639 of the housing 1630. Theactuator rod 1662 includes a first seal 1665 and a second seal 1666 andis in contact with an energy storage member 1667 such as a spring or thelike disposed within the actuator portion 1639 of the housing 1630. Inthe embodiment shown in FIGS. 51 and 52 , the arrangement of theactuator 1650 can be such that a first end portion of the actuator rod1662 is in selective contact with the pin 1677 of the diaphragm 1676 anda second end portion of the actuator rod 1662 (opposite the first endportion) is in contact with and/or otherwise is engaged with the energystorage member 1667.

As shown in FIG. 51 , when the actuator 1650 is in a first state, thepin 1677 of the diaphragm 1676 can engage the actuator rod 1662 tomaintain the actuator rod 1662 in a first or initial state and/orposition in which the energy storage member 1667 has a relatively highpotential energy (e.g., the energy storage member 1667 can be a springmaintained and/or held in a compressed state when in the first state).Furthermore, the first seal 1665 coupled to and/or disposed on theactuator 1662 is in a first or initial position in which the fluid flowpath 1633 establishes fluid communication between the inlet 1631 and thesequestration chamber 1634 when the actuator 1650 is in the first state.As shown, the second seal 1666 coupled to and/or disposed on theactuator rod 1662 is likewise in a first or initial position in whichthe second seal 1666 is spaced apart from a seal surface 1640 formed byat least a portion of the actuator portion 1639 of the housing 1630.

In some embodiments, the separation of the second seal 1666 from theseal surface 1640 can be such that the fluid flow path 1654 places theoutlet 1636 in fluid communication with the sequestration chamber 1634via a restricted flow path 1632 (see FIG. 52 ). In some embodiments, therestricted flow path 1632 can be similar in at least form and/orfunction to any of the restricted flow paths described herein (e.g., therestricted flow paths 232, 832, 1232, and/or 1332). As such, therestricted flow path 1632 can be configured to modulate a magnitude of anegative pressure differential applied on or in the sequestrationchamber 1634 and/or a rate at which a negative pressure differentialincreases within the sequestration chamber 1634. In other embodiments,the outlet 1636 can be in fluid communication with the sequestrationchamber 1634 via any suitable flow path, port, opening, valve, etc. Inother words, in some embodiments, the control device 1600 need notinclude the restricted flow path 1632.

As shown in FIG. 51 , when the actuator 1650 is in the first state, theactuator rod 1662 can be maintained in a first state or position inwhich the fluid flow path 1633 places the inlet 1631 in fluidcommunication with the sequestration chamber 1634, and the fluid flowpath 1654 places the outlet 1636 in fluid communication with thesequestration chamber 1634 via the restricted flow path 1632.Accordingly, when a fluid collection device (such as those describedherein) is coupled to the outlet 1636, a negative pressure defined inand/or otherwise produced by the fluid collection device can be operableto draw the initial volume of bodily fluid into the sequestrationchamber 1634.

As described in detail above, the actuator 1650 can be transitioned to asecond state and/or configuration in response to the initial volumebeing transferred into the sequestration chamber 1634. For example, insome embodiments, the initial volume of bodily fluid can be drawn intothe sequestration chamber 1634 in response to a negative pressure beingexerted through the flow controller 1642 (e.g., the selectivelypermeable membrane). In some instances, at least a portion of the bodilyfluid drawn into the sequestration chamber 1634 can come into contactwith the flow controller 1642, which in turn, can transition the flowcontroller 1642 from the first state to the second state (e.g., the flowcontroller 1642 limits and/or substantially prevents a flow of gas andliquid therethrough). As such, a negative pressure exerted on a surfaceof the diaphragm 1676 can build and can become sufficient to transition,move, and/or flip the diaphragm from a first state and/or configurationto a second state and/or configuration (see FIG. 52 ). In someembodiments, the transitioning of the diaphragm 1676 can correspond withand/or can be in response to the flow controller 1642 being transitionedfrom the first state to the second state (e.g., becoming fully wetted orthe like, as described in detail above). In other embodiments, thediaphragm 1676 can transition before or after the flow controller 1642has transitioned from the first state to the second state. In stillother embodiments, the control device 1600 need not include the flowcontroller 1642 and the diaphragm 1676 can be configured to transitionin response to being exposed to the negative pressure differentialproduced by the fluid collection device. In some such embodiments, thediaphragm 1676 (and/or at least a portion thereof) can be configured toact in a similar manner to the flow controller 1642 by transitioningfrom the first state to the second state in a predictable and/orpredetermined manner after being exposed to a predetermined negativepressure differential or a predetermined rate of change in negativepressure. Moreover, the transitioning of the diaphragm 1676 can beautomatic (e.g., is not a result of user intervention).

As shown in FIG. 52 , when the diaphragm 1676 is transitioned, moved,flipped, etc., the pin 1677 can be moved within the housing 1630 andrelative to the actuator rod 1662. More particularly, the transitioningof the diaphragm 1676 can move the pin 1677 a sufficient amount that thepin 1677 is disengaged from the actuator rod 1662. As such, the energystorage member 1667 (e.g., spring) can be configured to release and/orconvert at least a portion of its potential energy. As a specificexample, in this embodiment, moving the pin 1677 can allow the spring1667 to expand from a first or compressed state to a second orsubstantially uncompressed state. The transitioning of the energystorage member 1667 (e.g., spring) from the first state to the secondstate, in turn, moves the actuator rod 1662 within the actuator portion1639 from a first state and/or position to a second state and/orposition.

As shown in FIG. 52 , when the actuator rod 1662 is in the second stateand/or position, the first seal 1665 can be placed in a second orsubsequent position in which the first seal 1665 sequesters thesequestration chamber 1634 from the inlet 1631. Similarly, the secondseal 1666 can be placed in a second or subsequent position in which thesecond seal 1666 is pushed (e.g., by the energy storage member 1667)against the seal surface 1640, which in turn, sequesters the flowcontroller 1642 from the fluid flow path 1654. Furthermore, theplacement of the first seal 1665 and the second seal 1666 when theactuator rod 1662 is in the second state and/or position is such thatthe fluid flow path 1633 is placed in fluid communication with the fluidflow path 1654. Thus, a negative pressure differential produced by thefluid collection device coupled to the outlet 1636 can be operable todraw a subsequent volume of bodily fluid from the inlet 1631, throughthe fluid flow path 1633 and 1654, through the outlet 1636, and into thefluid collection device. Moreover, the collecting and sequestering ofthe initial volume of bodily fluid can result in the subsequentvolume(s) of bodily fluid being substantially free from contaminants, asdescribed in detail above.

Referring now to FIG. 53 , a flowchart is presented illustrating amethod 10 of using a fluid control device to obtain a bodily fluidsample with reduced contamination according to an embodiment. The fluidcontrol device can be similar to and/or substantially the same as any ofthe fluid control devices described in detail above. The method 10includes establishing fluid communication between a bodily fluid sourceand an inlet of the fluid collection device, at 11. For example, in someembodiments, a user can manipulate the fluid control device tophysically and/or fluidically couple the inlet to a lumen-containingdevice (e.g., a needle, IV, PICC line, etc.) in fluid communication witha patient.

A fluid collection device is coupled to an outlet of the fluid controldevice, at 12. The coupling of the fluid collection device to the outletis configured to produce a negative pressure differential within atleast a portion of the fluid control device, as described in detailabove. In some embodiments, for example, the fluid collection device canbe a sample bottle or container that defines a negative pressure. Inother embodiments, the fluid collection device can be a syringe or thelike that can be manipulated to produce a negative pressure.Accordingly, a negative pressure differential can be produced within oneor more portions of the fluid control device, as described above withreference to the control devices 100, 200, 300, 400, 500, 600, 700, 800,900, 1000, 1100, 1200, 1300, 1400, 1500, and/or 1600.

An initial volume of bodily fluid is received from the inlet and into asequestration portion of the fluid control device in response to thenegative pressure differential, at 13. For example, in some embodiments,the sequestration portion can be similar to and/or substantially thesame as the sequestration chamber 1234 described above with reference toFIGS. 29-34 . In other embodiments, the sequestration portion can besimilar to and/or substantially the same as the sequestration chamber1634. In still other embodiments, the sequestration portion can besimilar to and/or substantially the same as any of the sequestrationchambers described herein. Furthermore, in some instances, the initialvolume of bodily fluid can include contaminants entrained therein, whichmay otherwise result in false results during testing of a bodily fluidsample.

In response to contact with at least a portion of the initial volume ofbodily fluid, a flow controller disposed in the sequestration portion istransitioned from a first state in which the flow controller allows aflow of a gas through the flow controller and prevents a flow of bodilyfluid through the flow controller, to a second state in which the flowcontroller prevents a flow of gas and bodily fluid through the flowcontroller, at 14. For example, in some embodiments, the flow controllercan be a selectively permeable member or membrane (e.g., a fluid orblood barrier and/or the like), as described above with reference to theflow controller 242. In other embodiments, the flow controller can besimilar to and/or substantially the same as any of the flow controllersdescribed herein. Thus, in some embodiments, the contact with at leastthe portion of the initial volume of bodily fluid can, for example, wetor saturate the flow controller such that the flow controller limitsand/or substantially prevents a flow of gas and liquid (e.g., bodilyfluid) therethrough. In other embodiments, the flow controller can be abladder and/or diaphragm that is configured to be transitioned inresponse to a negative pressure differential. For example, in suchembodiments, a flow controller can be a substantially impermeablebladder or diaphragm that can transition from a first state to a secondstate when a negative pressure differential applied to a surface of thebladder and/or diaphragm exceeds a threshold amount of negativepressure.

The initial volume of bodily fluid is sequestered in the sequestrationportion after the flow controller is transitioned to the second state,at 15. For example, in some embodiments, the fluid control device caninclude an actuator and/or any other suitable feature or mechanismconfigured to transition after the flow controller is placed in itssecond configuration to sequester the initial volume of bodily fluid. Insome embodiments, the actuator can transition from a first state to asecond state to automatically sequester the initial volume of bodilyfluid in the sequestration portion, as described above with referenceto, for example, the actuator 1650. In other embodiments, the actuatorcan transition from a first state to a second state in response to aforce exerted by a user, as described above with reference to, forexample, the actuator 850. In still other embodiments, the fluid controldevice can sequester the initial volume of bodily fluid in thesequestration portion in any suitable manner such as those describedherein.

After sequestering the initial volume of bodily fluid, a subsequentvolume of bodily fluid is transferred from the inlet, through theoutlet, and into the fluid collection device, at 16. As described indetail above, in some instances, sequestering the initial volume ofbodily fluid in the sequestration portion of the fluid control devicecan likewise sequester contaminants contained in the initial volume.Accordingly, contaminants in the subsequent volume of bodily fluid canbe reduced or substantially eliminated.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where schematics and/or embodiments described above indicatecertain components arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. For example, while thecontrol devices 100, 200, 300, 400, 500, 600, 700, 800, 900, 1000, 1100,1200, 1300, 1400, and/or 1500 are described as transferring a bodilyfluid into the device as a result of a negative pressure within a fluidcollection device, in other embodiments, the devices described hereincan be used with any suitable device configured to establish a pressuredifferential (e.g., a negative pressure differential). For example, insome embodiments, an outlet of a control device can be coupled to asyringe or pump. In other embodiments, a control device can include apre-charged sequestration chamber, a vented sequestration chamber, amanually activated device configured to produce a negative pressure, anenergy source (e.g., a chemical energy source, a kinetic energy source,and/or the like), and/or any other suitable means of defining and/orforming a pressure differential within a portion of the control device.Moreover, as described above, the control devices can be coupled to suchcollection devices by a user (e.g., doctor, nurse, technician,physician, etc.) or can be coupled or assembled during manufacturing. Insome embodiments, pre-assembling a control device and a collectiondevice (e.g., a sample container or syringe) can, for example, forcecompliance with a sample procurement protocol that calls for thesequestration of an initial amount of bodily fluid prior to collecting asample volume of bodily fluid.

While some of the embodiments described above include a flow controllerand/or an actuator having a particular configuration and/or arrangement,in other embodiments, a fluid control device can include any suitableflow controller and/or actuator configured to selectively control a flowof bodily fluid through one or more portions of the fluid controldevice. For example, while some embodiments include an actuator such asa diaphragm or the like having one or more seals arranged as an O-ringor an elastomeric over-mold, which is/are moved with the diaphragm andrelative to a portion of the device (e.g., the inlet, the outlet, or anyother suitable portion) when the diaphragm is transitioned or flippedfrom a first state to a second state, in other embodiments, a fluidcontrol device can include one or more seals having any suitableconfiguration. For example, in some embodiments, a fluid control devicecan include one or more seals arranged as an elastomeric sheet or thelike that is/are fixedly coupled to a portion of the control device. Insuch embodiments, a portion of an actuator such as a pin or rodextending from a diaphragm (see e.g., FIGS. 11 and 12 ) can extendthrough an opening defined in the one or more elastomeric sheets, whichin turn, form a substantially fluid tight seal with an outer surface ofthe pin or rod. As such, when the actuator (e.g., diaphragm) istransitioned from a first state to a second state, the portion of theactuator (e.g., the pin or rod) can move through one or more of theelastomeric sheets. In other words, the portion of the actuator movesrelative to the one or more elastomeric sheets, which in turn, remain ina substantially fixed position relative to the portion of the controldevice. In some embodiments, the removal or the portion of the actuatorcan allow a flow of fluid through the opening defined by the one or moreelastomeric sheets that was otherwise occluded by the portion of theactuator. Accordingly, the one or more elastomeric sheets can functionin a similar manner as any of the seals described herein. Moreover, insome embodiments, such an arrangement may, for example, reduce an amountof friction associated with forming the desired fluid tight seals, whichin turn, may obviate the use of a lubricant otherwise used to facilitatethe movement of the seals within the control device.

While the diaphragms (e.g., diaphragms 576, 676, and 776) are describedherein as being configured to transition, move, flip, and/or otherwisereconfigure in response to an amount of negative pressure exerted on asurface of the diaphragm exceeding a threshold amount of negativepressure, in other embodiments, a fluid control device can include anysuitable actuator or the like configured to transition, move, flip,and/or otherwise reconfigure in response to being exposed to a desiredand/or predetermined amount of negative pressure. For example, in someembodiments, a fluid control device can include an actuator includingand/or arranged as a movable member, plug, plunger, occlusion member,seal, and/or the like configured to selectively control a flow of fluidthrough at least a portion of the fluid control device. Moreparticularly, the movable member or the like can be transitioned from afirst state and/or position in which the movable member or the like isdisposed in and/or otherwise occludes an opening, to a second stateand/or position in which the movable member or the like is removed fromthe opening. In such embodiments, a negative pressure can be exertedthrough a portion of the device to transfer, for example, an initialvolume of bodily fluid into a sequestration portion and/or chamber.

As described in detail above, in some embodiments, a device can includea flow controller such as a selectively permeable member or membrane,that can be configured to transition from a first state to a secondstate in response to being wetted (or otherwise transitioned) by theinitial volume of bodily fluid. After transferring the initial volume ofbodily fluid and after the flow controller is transitioned to its secondstate, an amount of negative pressure exerted on a surface of themovable member or the like may build until a magnitude of the negativepressure is sufficient to pull or move the movable member out of theopening, thereby allowing a flow of bodily fluid through the openingthat was otherwise occluded by the movable member. In this manner, themovable member can function similar to any of the diaphragms describedherein (e.g., the diaphragm 576, 676, and/or 776) that are configured totransition or flip from a first state to a second state. In suchembodiments, the movable member can be, for example, an elastomericplug, cork, plunger, and/or any other suitable member that can be movedor “popped” out of such an opening or portion of a flow path.

While some of the embodiments described above include a flow controllerand/or actuator that selectively establishes fluid communication betweena sequestration chamber and a fluid collection device (e.g., a samplereservoir, a syringe, and/or any other suitable source of negativepressure) in other embodiments, a control device can be arranged totransfer a flow of bodily fluid in response to negative pressuredifferentials resulting from any suitable portion(s) of the device. Forexample, while the control device 200 is described above as includingthe flow controller 242 and the restricted flow path 232 thatselectively place the sequestration chamber 234 in fluid communicationwith the sample reservoir until the flow controller 242 is transitionedto a sealed or closed state (e.g., until the flow controller 242 issufficiently wetted), in other embodiments, a control device can includea sequestration chamber that is a pre-sealed evacuated and/or chargedchamber such that establishing fluid communication between an inlet andthe sequestration chamber results in a negative pressure differentialthat is sufficient to draw an initial volume of bodily fluid into thesequestration chamber. In such embodiments, the control device can beconfigured to transfer bodily fluid to the sequestration chamber untilthe pressure differential is sufficiently reduced and/or until pressuresotherwise substantially equalize. Moreover, in some such embodiments,the sequestration chamber and/or the inlet can include a coupler, anactuator, a needle, a septum, a port, and/or any other suitable memberthat can establish fluid communication therebetween (e.g., that cantransition the sequestration chamber from a sealed to an unsealedconfiguration).

While some of the embodiments described above include a flow controllerand/or actuator that physically and/or mechanically sequesters one ormore portions of a fluid control device, in other embodiments, a fluidcontrol device need not physically and/or mechanically sequester one ormore portions of the fluid control device. For example, in someembodiments, an actuator such as the actuator 1250 can be transitionedfrom a first state in which an initial volume of bodily fluid can flowfrom an inlet to a sequestration chamber or portion, to a second statein which (1) the sequestration chamber or portion is physically and/ormechanically sequestered and (2) the inlet is in fluid communicationwith an outlet of the fluid control device. In other embodiments,however, an actuator and/or any other suitable portion of a fluidcontrol device can transition from a first state in which an initialvolume of bodily fluid can flow from an inlet to a sequestration chamberor portion, to a second state in which the inlet is placed in fluidcommunication with the outlet without physically and/or mechanicallysequestering (or isolating) the sequestration chamber or portion. Whensuch a control device is in the second state, one or more featuresand/or geometries of the control device can result in a preferentialflow of bodily fluid from the inlet to the outlet and the initial volumeof bodily fluid can be retained in the sequestration chamber or portionwithout physically and/or mechanically being sequestered or isolated.

While the restricted flow path 232 is described above as modulatingand/or controlling a magnitude of negative pressure applied on orthrough at least a portion of the device 200, in other embodiments, acontrol device can include any suitable feature, mechanism, and/ordevice configured to modulate, create, and/or otherwise control one ormore pressure differentials through at least a portion of the controldevice. For example, in some embodiments, a user can transition and/ormove an actuator to change (e.g., reduce or increase) the size of one ormore portions of a fluid flow path or fluid flow interface within aportion of the control device to manually modulate and/or otherwisecontrol an amount or magnitude of negative pressure within one or moreportions of a control device.

Although various embodiments have been described as having particularfeatures, concepts, and/or combinations of components, other embodimentsare possible having any combination or sub-combination of any features,concepts, and/or components from any of the embodiments describedherein. For example, as described above, the device 700 includesconcepts, features, and/or elements of the devices 200 and 600. Asanother example, any of the embodiments described herein can include alock or other suitable feature configured to at least temporarilymaintain one or more components in a desired position, state,arrangement, and/or configuration. As another example, any of theembodiments described herein can include and/or can define asequestration chamber and/or portion that is configured similar to, forexample, the sequestration chamber 1234 described above with referenceto FIG. 30 . In other words, any of the fluid control devices describedherein can include a sequestration chamber that is arranged and/orformed as a channel. In some embodiments, a channel forming at least aportion of a sequestration chamber can have a relatively smallcross-sectional shape and/or size that can reduce and/or substantiallyprevent mixing of air and bodily fluid as the initial volume of bodilyfluid is drawn into the channel, as described above with reference tothe sequestration chamber 1234. Moreover, such a channel can have aspiral shape and/or configuration similar to the sequestration chamber1234 described above and/or can have any other suitable shape and/orconfiguration.

As another example, any of the control devices described herein caninclude a flow controller arranged as a selectively permeable member ormembrane as described above, for example, with reference to the flowcontroller 242. More particularly, while the control device 600 is notdescribed as including a flow controller, in other embodiments, aportion of the diaphragm 676 can include and/or can form a flowcontroller formed, at least in part, of a selectively permeablematerial. In such embodiments, the flow controller can be configured toallow a volume of the sequestration chamber and/or portion 634 to bevented in response to being exposed to the negative pressuredifferential (as described above). In other words, a volume of air canbe drawn out of (e.g., vented from or purged from) the sequestrationchamber 634 via the flow controller in response to the negative pressuredifferential within a portion of the fluid control device 600. In someinstances, such an arrangement can allow for a reduction in a sizeand/or volume of the sequestration chamber 634 because a volume of airotherwise occupying a portion of the sequestration chamber 634 is ventedor purged through the flow controller in response to the negativepressure differential.

By way of another example, any of the embodiments described herein caninclude any suitable actuator and/or flow controller configured toselectively control fluid flow through at least a portion of the device.Specifically, a flow controller or the like can be one or more of aselectively permeable material or membrane, a valve, a diaphragm, and/orany other suitable flow controller. While some of the embodiments havebeen described as including an actuator rod configured to betransitioned from a first configuration or position to a secondconfiguration or position (e.g., the actuator rod 1262 of the actuator1250), in other embodiments, any actuator described herein can includean actuator rod configured to transition from between a first positionand second position to at least temporarily isolate an outlet of thedevice from one or more other portions of the device (e.g., as describedabove with reference to the actuators 850 and/or 1350). In someembodiments, such an actuator can be configured for use with a givenand/or predetermined collection device such as, for example, a syringe.In other embodiments, such an actuator can be used with any suitablecollection device.

In some embodiments, the specific configurations of the variouscomponents can also be varied. For example, the size and specific shapeof the various components can be different from the embodiments shown,while still providing the functions as described herein. For example,while a portion of the actuator body 1551, sequestration chamber 1534,and/or the bladder 1578 are shown in FIGS. 45-50 as being substantiallytubular having a round or substantially semi-circular end portion, inother embodiments, the portion of the actuator body 1551, sequestrationchamber 1534, and/or bladder 1578 can have any suitable shape and/orsize. In some embodiments, varying the size and/or shape of suchcomponents may reduce an overall size of the device 1500 and/or mayincrease the ergonomics of the device 1500 without changing the functionof the device 1500. As a specific example, a housing, sequestrationchamber, and/or bladder may have a substantially cylindrical shape witha relatively flat end portion or the like. Moreover, in someembodiments, a control device can include a bladder that is configuredto “flip” similar to the diaphragms described above in response to beingexposed to a negative pressure differential. In other embodiments, abladder can be configured to gradually transition (e.g., unroll, unfold,unfurl, and/or otherwise reconfigure) from the first state to the secondstate. In some instances, controlling a rate at which a bladder istransitioned may allow for a modulation and/or control of a negativepressure differential produced within the sequestration chamber.

In other embodiments, a device may include a bladder (similar in formand/or function to the bladders 1478 and/or 1578) disposed in a housinghaving a size, shape, and/or profile similar to the housings 1230 and/or1330. In some such embodiments, the bladder can define a volume that issimilar in shape and/or size the overall size, and/or shape of thehousing (e.g., cylindrical with a relatively low profile or height). Insome instances, such an arrangement can allow at least a portion of aninitial volume of bodily fluid to remain in contact with a surface ofthe bladder (or diaphragm or other actuator), which can provide a visualindication to the user regarding the bodily fluid being transferred intothe sequestration chamber. In other embodiments, a housing similar tothe housing 1230 can define a spiral channel or any other suitablechannel and can include a bladder disposed within at least a portion ofthat channel. In such embodiments, the bladder can function similarly tothe bladder 1578 in which the bladder expands, opens, and/or otherwiseincreases in volume in response to being exposed to a negative pressuredifferential. In some embodiments, a bladder can define an enclosedvolume configured to receive an initial volume of bodily fluid. In otherembodiments, the bladder and a portion of the housing (e.g., a surfacedefining the sequestration chamber and/or channel) can collectivelydefine the volume configured to receive the initial volume of bodilyfluid. In this manner, a fluid control device can include a bladderconfigured to conform to any suitable shape, feature, channel, and/orconfiguration of a housing in which it is disposed. In some embodiments,the size and shape of the various components can be specificallyselected for a desired rate and/or volume of bodily fluid flow into afluid reservoir.

In some embodiments, the size and/or shape of the various components canbe specifically selected for a desired or intended usage. For example,in some embodiments, a device such as those described herein can beconfigured for use with or on seemingly healthy adult patients. In suchembodiments, the device can include a sequestration chamber that has afirst volume (e.g., about 0.5 ml to about 5.0 ml). In other embodiments,a device such as those described herein can be configured for use withor on, for example, very sick patients and/or pediatric patients. Insuch embodiments, the device can include a sequestration chamber thathas a second volume that is less than the first volume (e.g., less thanabout 0.5 ml). Thus, it should be understood that the size, shape,and/or arrangement of the embodiments and/or components thereof can beadapted for a given use unless the context explicitly states otherwise.

Although not shown, any of the devices described herein can include anopening, port, coupler, septum, Luer-Lok, gasket, valve, threadedconnecter, standard fluidic interface, etc. (referred to for simplicityas a “port”) in fluid communication with the sequestration chamber. Insome such embodiments, the port can be configured to couple to anysuitable device, reservoir, pressure source, etc. For example, in someembodiments, the port can be configured to couple to a reservoir, whichin turn, can allow a greater volume of bodily fluid to be divertedand/or transferred into the sequestration chamber. In other embodiments,the port can be coupled to a negative pressure source such as anevacuated container, a pump, a syringe, and/or the like to collect aportion of or the full volume of bodily fluid in the sequestrationchamber, channel, reservoir, etc. and use that volume of bodily fluid(e.g., the pre-sample volume) for additional clinical and/or in vitrodiagnostic testing purposes. In other embodiments, the port can beconfigured to receive a probe, sampling tool, testing device, and/or thelike that can be used to perform one or more tests (e.g., tests notsensitive to potential contamination) on the initial volume while theinitial volume is disposed or sequestered in the sequestration chamber.In still other embodiments, the port can be coupled to any suitablepressure source or infusion device configured to infuse the initialvolume of bodily fluid sequestered in the sequestration chamber backinto the patient and/or bodily fluid source (e.g., in the case ofpediatric patients, very sick patients, patients having a low bloodvolume, and/or the like). In other embodiments, the sequestrationchannel, chamber, and/or reservoir can be configured with the additionof other diagnostic testing components integrated into the chamber(e.g., a paper test) such that the initial bodily fluid is used for thattest.

In still other embodiments, the sequestration chamber, channel, and/orreservoir can be designed, sized, and configured to be removable andcompatible with testing equipment and/or specifically accessible forother types of bodily fluid tests commonly performed on patients withsuspected conditions. By way of example, a patient with suspected sepsiscommonly has blood samples collected for lactate testing, procalcitonintesting, and blood culture testing. All of the fluid control devicesdescribed herein can be configured such that the sequestration chamber,channel, reservoir, etc. can be removed (e.g., after receiving theinitial volume of bodily fluid) and the bodily fluid contained thereincan be used for these additional testing purposes before or after thesubsequent sample is collected for microbial testing.

Although not shown, in some embodiments, a fluid control device caninclude one or more lumen, channels, flow paths, etc. configured toselectively allow for a “bypass” flow of bodily fluid, where an initialamount or volume of bodily fluid can flow from the inlet, through thelumen, cannel, flow path, etc. to bypass the sequestration chamber, andinto the collection device. In some embodiments, the fluid controldevice can include an actuator having, for example, at least threestates—a first in which bodily fluid can flow from the inlet to thesequestration chamber, a second in which bodily fluid can flow from theinlet to the outlet after the initial volume is sequestered in thesequestration chamber, and a third in which bodily fluid can flow fromthe inlet, through the bypass flow path, and to the outlet. In otherembodiments, the control device can include a first actuator configuredto transition the device between a first and second state, as describedin detail above with reference to specific embodiments, and can includea second actuator configured to transition the device to a bypassconfiguration or the like. In still other embodiments, the controldevice can include any suitable device, feature, component, mechanism,actuator, controller, etc. configured to selectively place the fluidcontrol device in a bypass configuration or state.

Any of the embodiments described herein can be used in conjunction withany suitable fluid transfer, fluid collection, and/or fluid storagedevice such as, for example, the fluid reservoirs described in the '420patent. In some instances, any of the embodiments described herein canbe used in conjunction with any suitable transfer adapter, fluidtransfer device, fluid collection device, and/or fluid storage devicessuch as, for example, the devices described in the '510 Publicationand/or any of the devices described in U.S. Patent Publication No.2015/0246352 entitled, “Apparatus and Methods for Disinfection of aSpecimen Container,” filed Mar. 3, 2015; U.S. Pat. No. 8,535,241entitled, “Fluid Diversion Mechanism for Bodily-Fluid Sampling,” filedOct. 12, 2012; U.S. Pat. No. 9,060,724 entitled, “Fluid DiversionMechanism for Bodily-Fluid Sampling,” filed May 29, 2013; U.S. Pat. No.9,155,495 entitled, “Syringe-Based Fluid Diversion Mechanism forBodily-Fluid Sampling,” filed Dec. 2, 2013; U.S. patent Publication No.2016/0361006 entitled, “Devices and Methods for Syringe Based FluidTransfer for Bodily-Fluid Sampling,” filed Jun. 13, 2016; U.S. PatentPublication No. 2018/0140240 entitled, “Systems and Methods for SampleCollection with Reduced Hemolysis,” filed Nov. 20, 2017; and/or U.S.Patent Publication No. 2017/0065733 entitled, “Apparatus and Methods forMaintaining Sterility of a Specimen Container,” filed Sep. 6, 2016, thedisclosures of each of which are incorporated herein by reference intheir entireties.

In some embodiments, a method of using a fluid control device such asthose described herein can include the ordered steps of establishingfluid communication between a bodily fluid source (e.g., a vein of apatient or the like) and an inlet of a fluid control device. An outletof the fluid control device is then placed in fluid communication withand/or otherwise engages a negative pressure source. Such a negativepressure source can be a sample reservoir, a syringe, an evacuatedcontainer, an intermediate transfer device, and/or the like. The fluidcontrol device can be in a first state or operating mode when the outletis coupled to the negative pressure source and, as such, a negativepressure differential is applied through the fluid control device thatdraws an initial volume of bodily fluid into a sequestration chamber ofthe fluid control device. For example, a negative pressure within asample reservoir can be operable in drawing an initial volume of bodilyfluid from a patient and into the sequestration chamber. Once theinitial volume of bodily fluid is disposed in the sequestration chamber,the fluid control device is transitioned, either automatically or viauser intervention, from the first state or operating mode to a secondstate or operating mode such that (1) the initial volume is sequesteredin the sequestration chamber and (2) the fluid communication isestablished between the inlet and the outlet. The sequestration of theinitial volume can be such that contaminants entrained in the flow ofthe initial volume are likewise sequestered within the sequestrationchamber. With the initial volume of bodily fluid sequestered in thesequestration chamber and with fluid communication established betweenthe inlet and the outlet, subsequent volumes of bodily fluid that aresubstantially free of contamination can be collected in one or moresample reservoirs.

While the method of using the fluid control device is explicitlydescribed as including the recited ordered steps, in other embodiments,the ordering of certain events and/or procedures in any of the methodsor processes described herein may be modified and such modifications arein accordance with the variations of the invention. Additionally,certain events and/or procedures may be performed concurrently in aparallel process when possible, as well as performed sequentially asdescribed above. Certain steps may be partially completed or may beomitted before proceeding to subsequent steps. For example, while thedevices are described herein as transitioning from a first state to asecond state in a discrete operation or the like, it should beunderstood that the devices described herein can be configured toautomatically and/or passively transition from the first state to thesecond state and that such a transitioning may occur over a period oftime. In other words, the transitioning from the first state to thesecond state may, in some instances, be relatively gradual such that asa last portion of the initial volume of bodily fluid is beingtransferred into the sequestration chamber, the housing begins totransition from the first state to the second state. In some instances,the rate of change when transitioning from the first state to the secondstate can be selectively controlled to achieve one or more desiredcharacteristics associated with the transition. Moreover, in some suchinstances, the inflow of the last portion of the initial volume canlimit and/or substantially prevent bodily fluid already disposed in thesequestration chamber from escaping therefrom. Accordingly, while thetransitioning from the first state to the second state may occur over agiven amount of time, the sequestration chamber can nonethelesssequester the volume of bodily fluid disposed therein.

1.-36. (canceled)
 37. A fluid control device, the device comprising: ahousing having an inlet fluidically coupleable to a bodily-fluid sourceand an outlet fluidically coupleable to a fluid collection device, thehousing defining at least a portion of each of a containment channel anda sampling channel between the inlet and the outlet; a selectivelypermeable blood barrier, the blood barrier fluidically coupled to thecontainment channel and the outlet; and a valve disposed at leastpartially in the housing and configured to substantially obstruct a flowpath between the inlet and the outlet when in a first state, the bloodbarrier configured to allow a gas to flow through the blood barrier inresponse to a pressure differential between the inlet and the outlet,thereby allowing a volume of blood to flow into the containment channel,in response to contact with at least a portion of the volume of theblood in the containment channel, the blood barrier configured to allowthe pressure differential in at least a portion of the sampling channelbetween the valve and the outlet to build to an extent sufficient totransition the valve from the first state to a second state in which thevalve allows blood to flow through the sampling channel to the outlet.38. The device of claim 37, wherein the valve is configured to open inresponse to a predetermined pressure differential.
 39. The device ofclaim 37, wherein the valve is a one-way valve.
 40. The device of claim37, wherein the valve is a duckbill valve.
 41. The device of claim 37,wherein the valve is an umbrella valve.
 42. The device of claim 37,wherein the housing defines at least a portion of a flow path between aproximal end portion of the containment channel and the outlet, at leasta portion of the flow path is configured to modulate the pressuredifferential between the inlet and the outlet as the volume of blood isdrawn into the containment channel.
 43. The device of claim 37, whereinthe valve in the second state is configured to allow blood to flow fromthe bodily-fluid source to the outlet via the sampling channel while atleast a portion of the volume of blood is contained in the containmentchannel.
 44. The device of claim 37, wherein the valve is formed of anelastomeric material.
 45. The device of claim 37, wherein the valve isconfigured to transition from the first state to the second statewithout manual intervention.
 46. A fluid control device, the devicecomprising: a housing having an inlet and an outlet, the housing atleast partially defining each of a containment channel and a samplingchannel between the inlet and the outlet; a selectively permeable bloodbarrier disposed at least partially in the housing in fluidiccommunication with the containment channel and the outlet, the bloodbarrier configured to allow a gas to flow from the containment channelto the outlet in response to a pressure differential between the inletand the outlet such that a volume of blood flows from the inlet into thecontainment channel; and a valve disposed at least partially in thehousing between at least a portion of the sampling channel and theinlet, the valve in a first state configured to prevent the volume ofblood from flowing from the inlet to the outlet, the valve configured totransition from the first state to a second state in response to anincrease in a pressure differential between the valve and the outlet asa result of the volume of blood in the containment channel such that asubsequent volume of blood is drawn from the inlet through the samplingchannel and to the outlet.
 47. The device of claim 46, wherein the valveis configured to open in response to a predetermined pressuredifferential.
 48. The device of claim 46, wherein the valve is a one-wayvalve.
 49. The device of claim 46, wherein the valve is a duckbillvalve.
 50. The device of claim 46, wherein the valve is an umbrellavalve.
 51. The device of claim 46, further comprising: a flow pathbetween a proximal end portion of the containment channel and theoutlet, at least a portion of the flow path is configured to modulatethe pressure differential between the inlet and the outlet as the volumeof blood is drawn into the containment channel.
 52. The device of claim46, wherein the valve in the second state is configured such that thesubsequent volume of blood is drawn from the inlet to the outlet via thesampling channel while at least a portion of the volume of blood iscontained in the containment channel.
 53. The device of claim 46,wherein the valve is formed of an elastomeric material.
 54. The deviceof claim 46, wherein the valve is configured to transition from thefirst state to the second state without manual intervention.
 55. A fluidcontrol device, the device comprising: a housing having an inlet and anoutlet, the housing at least partially defining each of a containmentchannel and a sampling channel between the inlet and the outlet; aselectively permeable blood barrier, the blood barrier disposed at leastpartially in the housing between the containment channel and the outlet;and a valve disposed at least partially in the housing between at leasta portion of the sampling channel and the inlet, the blood barrierconfigured to allow a gas to flow from the containment channel to theoutlet in response to a first pressure differential between the inletand the outlet such that a volume of blood flows into the containmentchannel, the valve configured to transition from a first state to asecond state in response to a second pressure differential greater thanthe first pressure differential between the valve and the outlet as aresult of the volume of blood in the containment channel, the valve inthe first state configured to prevent the volume of blood from flowingfrom the inlet to the outlet via the sampling channel and the valve inthe second state configured to allow a subsequent volume of blood toflow from the inlet through the sampling channel to the outlet.
 56. Thedevice of claim 55, wherein the valve is configured to open in responseto a predetermined pressure differential.
 57. The device of claim 55,wherein the valve is a one-way valve.
 58. The device of claim 55,wherein the valve is a duckbill valve.
 59. The device of claim 55,wherein the valve is an umbrella valve.
 60. The device of claim 55,further comprising: a flow path between a proximal end portion of thecontainment channel and the outlet, at least a portion of the flow pathis configured to modulate the pressure differential between the inletand the outlet as the volume of blood is drawn into the containmentchannel.
 61. The device of claim 55, wherein the valve in the secondstate is configured such that the subsequent volume of blood is drawnfrom the inlet to the outlet via the sampling channel while at least aportion of the volume of blood is contained in the containment channel.62. The device of claim 55, wherein the valve is formed of anelastomeric material.
 63. The device of claim 55, wherein the valve isconfigured to transition from the first state to the second statewithout manual intervention.
 64. A fluid control device, the devicecomprising: a containment channel defined between an inlet and anoutlet; a sampling channel defined between the inlet and the outlet; aselectively permeable blood barrier at a proximal end portion of thecontainment channel, the blood barrier configured to allow a gas to flowfrom the containment channel to the outlet in response to a pressuredifferential between the inlet and the outlet such that a volume ofblood flows from a bodily-fluid source, through the inlet, and into thecontainment channel; and a valve in fluidic communication with at leasta portion of the containment channel and sampling channel, the valve ina first state configured to prevent the blood from flowing from theinlet to the outlet via the sampling channel, the valve configured totransition to a second state in response to a pressure differential inat least a portion of the sampling channel between the valve and theoutlet exceeding a threshold pressure as a result of the volume of bloodin the containment channel, the valve in the second state configured toallow blood to flow through the sampling channel to the outlet.
 65. Thedevice of claim 64, wherein the valve is configured to open in responseto a predetermined pressure valve.
 66. The device of claim 64, whereinthe valve is a one-way valve.